Polux , Minerva and Atropos PTA Balloon Dilatation Catheter

K160256 · Brosmed Medical Co., Ltd. · LIT · Jul 29, 2016 · Cardiovascular

Device Facts

• Record ID: K160256
• Device Name: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
• Applicant: Brosmed Medical Co., Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Device Story

Polux, Minerva, and Atropos are over-the-wire (OTW) peripheral PTA balloon dilatation catheters. Devices consist of a coaxial double-lumen catheter with a semi-compliant Pebax balloon at the distal tip. One lumen facilitates balloon inflation via a side leg port; the second lumen allows guidewire insertion. Radiopaque markers aid in positioning relative to stenosis. Used in clinical settings by physicians to dilate peripheral arterial stenoses or post-deploy stents. Inflation expands the balloon to a known diameter based on pressure; working pressure ranges between nominal and rated burst pressure (14 atm). Benefits include restoration of vessel patency and improved blood flow in peripheral vasculature.

Clinical Evidence

Bench testing only. Performance data included dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond/tip pull strength, flexibility, kinking, torque, radiopacity, coating integrity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity, and genotoxicity. All results met acceptance criteria.

Technological Characteristics

Coaxial double-lumen catheter; semi-compliant Pebax balloon; 1.5-10.0 mm diameters; 5-200 mm lengths; 70/90/150 cm working lengths; 14 atm rated burst pressure; radiopaque marker bands; guidewire compatibility 0.014" (Polux), 0.018" (Minerva), 0.035" (Atropos).

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae; also indicated for post-deployment stent dilatation in peripheral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• NanoCross Elite 0.014" Over-The-Wire PTA Balloon Dilatation Catheter (K141118)
• Sterling Over-The-Wire (OTW) PTA Balloon Dilatation Catheter (K132430)
• Mustang Balloon Dilatation Catheters (K103751)

Submission Summary (Full Text)

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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" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines connecting them.

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

July 29, 2016

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

Re: K160256

Trade/Device Name: Polux, Minerva, and Atropos PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 05, 2016 Received: July 08, 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

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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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K160256

#### Device Name

Polux PTA Balloon Dilatation Catheter Minerva PTA Balloon Dilatation Catheter Atropos PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The balloon dilatation catheter is intended to dilac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

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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## 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 | July 29, 2016 |
| Trade Name: | Polux PTA Balloon Dilatation Catheter<br>Minerva PTA Balloon Dilatation Catheter<br>Atropos PTA Balloon Dilatation Catheter |
| Common Name: | PTA Balloon Dilatation Catheter |
| Classification Name: | Percutaneous catheter (21 CFR 870.1250, Product Code LIT) |
| Predicate Devices: | NanoCross Elite 0.014" Over-The-Wire PTA Balloon Dilatation Catheter<br>(K141118; cleared July 18, 2014)<br>Sterling Over-The-Wire (OTW) PTA Balloon Dilatation Catheter<br>(K132430; cleared October 17, 2013)<br>Mustang Balloon Dilatation Catheters<br>(K103751; cleared March 22, 2011) |
| Device Description: | The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are over-<br>the-wire (OTW) peripheral balloon catheters designed for Percutaneous<br>Transluminal Angioplasty (PTA). These three PTA balloon dilatation catheters<br>have been bundled in one 510(k) submission due to the similar/equivalent<br>construction and identical material of the products. As summarized by the<br>comparison between the Polux, Minerva, and Atropos PTA Balloon Dilatation<br>Catheters in Table 1, the devices only differ in guidewire compatibility, balloon<br>diameter, and balloon length. The devices are offered with catheter working<br>lengths of 70, 90 and 150 cm. The guidewire compatibility includes 0.014" for<br>the Polux device, 0.018" for the Minerva device and 0.035" for the Atropos<br>device. The balloon diameters range from 1.5 mm to 10.0 mm, with balloon<br>working lengths ranging from 5 mm to 200 mm.<br>The balloon material is made of a semi-compliant Pebax material and offered in<br>diameters 1.5 mm to 10.0 mm with a rated burst pressure of 14 atmospheres. It<br>is a coaxial double lumen catheter with a balloon located near the distal tip. One<br>lumen is used for inflation of the balloon and accessed via the side leg port. The<br>second lumen, starting at the straight entry port, allows access to the distal tip of<br>the catheter for guide wire insertion. The balloon has radiopaque markers for<br>positioning the balloon relative to the stenosis. The radiopaque marker bands<br>indicate the dilating section of the balloon and aid in balloon placement. The<br>balloon is dilated using the side leg port, at which the balloon material expands<br>to a known diameter depending on the pressure delivered. The working pressure<br>range for the balloon is between the nominal size pressure and the rated burst<br>pressure. All balloons distend to sizes above the nominal size at pressures<br>greater than the nominal pressure. The design of this dilatation catheter does not<br>incorporate a lumen for distal dye injections or distal pressure measurements. |

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The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, Intended Use: iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature Technological Characteristics: Comparing the subject devices against their corresponding predicates reveal similarities in technological characteristics including: indications for use, operating principle. guidewire compatibility. catheter design. sheath compatibility, sterilization method, sterility assurance level, and similar ranges of balloon diameters, balloon effective lengths, and catheter working lengths. The major differences between the subject and predicate devices include materials, smaller balloon lengths, and different balloon configurations. Performance Data: Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, particulate evaluation, balloon burst (in stents, balloon fatigue (in stent) and also biocompatibility tests. such as cytotoxicity, sensitization. hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the PTA balloon catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use. Conclusion: This information supports the determination of substantial equivalence between the PTA balloon dilatation catheter and the predicate devices described above.

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## Table 1: Comparison of Technical Characteristics between the Subject Devices (BrosMed Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters)

| | Polux 0.014" | Minerva 0.018" | Atropos 0.035" | Difference | Control<br>Method |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------|
| Device | catheter, angioplasty,<br>peripheral, transluminal | catheter, angioplasty,<br>peripheral, transluminal | catheter, angioplasty,<br>peripheral, transluminal | Identical | n/a |
| Regulation<br>Description | Percutaneous catheter. | Percutaneous catheter. | Percutaneous catheter. | Identical | |
| Regulation<br>Medical Specialty | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Product Code | LIT | LIT | LIT | Identical | |
| Premarket Review | Office of Device Evaluation<br>6(ODE)<br>Division of Cardiovascular<br>Devices (DCD) | Office of Device Evaluation<br>6(ODE)<br>Division of Cardiovascular<br>Devices (DCD) | Office of Device Evaluation<br>6(ODE)<br>Division of Cardiovascular<br>Devices (DCD) | Identical | |
| | Peripheral Interventional<br>Devices Branch (PIDB) | Peripheral Interventional<br>Devices Branch (PIDB) | Peripheral Interventional<br>Devices Branch (PIDB) | Identical | |
| Submission Type | 510(k) | 510(k) | 510(k) | Identical | |
| Regulation<br>Number | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Identical | |
| Device Class | 2 | 2 | 2 | Identical | |
| Intended Use | The<br>balloon<br>dilatation<br>catheter is intended to dilate<br>stenoses in the iliac, femoral,<br>iliofemoral,<br>popliteal,<br>infrapopliteal,<br>and<br>renal<br>arteries, and for the treatment<br>of obstructive lesions of native<br>or synthetic arteriovenous<br>dialysis fistulae.<br>This device is also indicated<br>for stent post-dilatation in the<br>peripheral vasculature | The<br>balloon<br>dilatation<br>catheter is intended to dilate<br>stenoses in the iliac, femoral,<br>iliofemoral,<br>popliteal,<br>infrapopliteal,<br>and<br>renal<br>arteries, and for the treatment<br>of obstructive lesions of native<br>or synthetic arteriovenous<br>dialysis fistulae.<br>This device is also indicated<br>for stent post-dilatation in the<br>peripheral vasculature | The<br>balloon<br>dilatation<br>catheter is intended to dilate<br>stenoses in the iliac, femoral,<br>iliofemoral,<br>popliteal,<br>infrapopliteal,<br>and<br>renal<br>arteries, and for the treatment<br>of obstructive lesions of native<br>or synthetic arteriovenous<br>dialysis fistulae.<br>This device is also indicated<br>for stent post-dilatation in the<br>peripheral vasculature | Identical | IFU |
| Balloon<br>Characteristic | semi-compliant | semi-compliant | semi-compliant | Identical | Design<br>Verification;<br>labeling |
| Nominal<br>Pressure (Nom) | 6atm | 6atm | 6atm | Identical | Design<br>Verification;<br>labeling |
| Rated Burst<br>Pressure (RBP) | 14atm | 14atm | 14atm | Identical | Design<br>Verification;<br>labeling |
| Guide wire<br>Compatibility | Max. 0.014"(0.36mm) | Max. 0.018" (0.46mm) | Max. 0.035"(0.89mm) | Different | Design<br>Verification;<br>labeling |
| Balloon<br>Diameter | 1.5-6.0mm | 1.5-10.0mm | 3.0-10.0mm | Different | Design<br>Verification;<br>labeling |
| Balloon Length | 5-200mm | 5-200mm | 20-200mm | Different | Design<br>Verification;<br>labeling |
| Shaft Length | 70,90,150 | 70,90,150 | 70,90,150 | Identical | Design<br>Verification;<br>labeling |