Apollo Balloon Dilatation Catheter

K153742 · Brosmed Medical Co., Ltd. · LOX · Aug 8, 2016 · Cardiovascular

Device Facts

• Record ID: K153742
• Device Name: Apollo Balloon Dilatation Catheter
• Applicant: Brosmed Medical Co., Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: Aug 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The balloon dilatation catheter is indicated for: • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion • balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction • balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only) Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

Device Story

Apollo Balloon Dilatation Catheter is a rapid-exchange PTCA catheter used by interventional cardiologists in a clinical setting. It features a minimally compliant balloon (2.0mm–5.0mm diameter) mounted on a catheter shaft. The device is advanced over a standard 0.014-inch guidewire to the target coronary lesion. Inflation of the balloon via a luer connector allows for mechanical dilatation of stenotic vessels or post-stent expansion. Radiopaque platinum/iridium marker bands facilitate fluoroscopic positioning. The device improves myocardial perfusion by restoring vessel patency. It does not include lumens for dye injection or pressure measurement.

Clinical Evidence

Bench testing only. In vitro performance 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, coating integrity, and particulate evaluation. Biocompatibility and radiopacity were leveraged from predicate device K133852 due to identical materials and manufacturing processes.

Technological Characteristics

Minimally compliant balloon; PTFE-coated stainless steel proximal shaft; nylon outer distal tube; tri-extrusion inner tube; platinum/iridium radiopaque marker bands. Rapid-exchange design for 0.014-inch guidewires. Rated burst pressure: 22 atm (2.0-4.0mm) or 20 atm (4.5-5.0mm).

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic coronary arteries, bypass graft stenosis, or coronary artery occlusions (including acute myocardial infarction), and for post-stent implantation dilatation.

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

• Apollo Balloon Dilatation Catheter (K133852)
• NC Sprinter RX (P790017S095)
• Voyager NC (P810046S226)
• Quantum Maverick (P860019S182)
• NC Quantum (P860019S241)
• Dura Star (P880003S089)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

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

August 8, 2016

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

Re: K153742

Trade/Device Name: Apollo Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: July 4, 2016 Received: July 8. 2016

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 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

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

the quality systems (OS) 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,

## 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

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

## Indications for Use

510(k) Number (if known) K153742

Device Name Apollo Balloon Dilatation Catheter

Indications for Use (Describe)

The balloon dilatation catheter is indicated for:

- · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
- · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
- · balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

## 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] |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen Lee |
| Date Prepared | Aug, 05, 2016 |
| Trade Name: | Apollo Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21<br>CFR<br>870.5100(a), Product Code LOX) |
| Predicate Devices: | Apollo Balloon Dilatation Catheter (K133852; cleared September 19, 2014)<br>NC Sprinter RX (P790017S095; cleared October 10, 2008)<br>Voyager NC (P810046S226; cleared August 21, 2008)<br>Quantum Maverick (P860019S182; cleared October 1, 2002)<br>NC Quantum (P860019S241; cleared April 16, 2010)<br>Dura Star (P880003S089; cleared August 29, 2007) |
| Device Description: | The Apollo Balloon Dilatation Catheter is designed to allow easy exchange<br>of the catheter using a standard length guidewire. Balloon diameters<br>range from 2.0mm to 5.0mm. The balloon material is made of a minimally<br>compliant material with a rated burst pressure of 22 atmospheres for Ø2.0-<br>4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The<br>minimally compliant balloon material will allow high pressure dilatation<br>while maintaining precise control of the balloon diameter and length.<br>The<br>proximal shaft of the catheter is composed of a female luer connector<br>bonded to a PTFE coated stainless steel tube. The proximal shaft allows<br>superior proximal pushability with a smooth transition to a distal shaft<br>composed of an outer tube of nylon and a tri-extrusion inner tube with a<br>balloon laser welded to both tubes at the distal tip. Two radiopaque<br>platinum/iridium marker bands are positioned within the balloon shoulders.<br>The inner tube accepts a standard 0.014 inch PTCA guidewire. The<br>guidewire enters the catheter tip and advances coaxially out the distal Rx<br>port, thereby allowing both coaxial guidance and rapid exchange of catheter<br>with a single standard length guidewire. Two marked sections, 5mm in<br>length located on the proximal shaft, indicate catheter position relative to<br>the tip of either a brachial or femoral guiding catheter. The design of this<br>dilatation catheter does not incorporate a lumen for distal dye injections or<br>distal pressure measurements. |
| Intended Use: | The balloon dilatation catheter is indicated for:<br>• balloon dilatation of the stenotic portion of a coronary artery or bypass<br>graft stenosis for the purpose of improving myocardial perfusion |
| | ● balloon dilatation of a stent after implantation (balloon models 2.00<br>mm - 5.00 mm only) |
| | Note: Bench testing was conducted with the Apollo Balloon Dilatation<br>Catheter and marketed balloon expandable stents. Consideration should be<br>taken when this device is used with different manufacturers' stents due to<br>difference in stent design. |
| Technological<br>Characteristics: | Comparisons of the new and predicate devices show that the technological<br>characteristics such as product performance, design, and intended use are<br>substantially equivalent to the currently marketed predicate devices. |
| Performance Data: | In vitro performance tests, such as dimensional verification, balloon<br>preparation, deployment, and retraction, balloon rated burst pressure,<br>balloon fatigue, balloon compliance, balloon inflation and deflation time,<br>catheter bond strength, tip pull strength, flexibility and kinking, torque<br>strength, coating integrity, and particulate evaluation were conducted on the<br>Apollo PTCA catheter. The test results met all acceptance criteria, and were<br>similar to predicate devices. Radiopacity and Biocompatibility tests were<br>leveraged from predicate devices based on the use of same materials and<br>processes as the predicates (K133852; cleared September 19, 2014). The<br>test results ensure that the Apollo Balloon Dilatation Catheter design and<br>construction are suitable for its intended use. |
| Conclusion: | This information supports as determination of substantial equivalence<br>between the Apollo Balloon Dilatation Catheter and the predicate devices<br>described above. |

- balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

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