Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter

K160941 · Brosmed Medical Co., Ltd. · LIT · Dec 13, 2016 · Cardiovascular

Device Facts

• Record ID: K160941
• Device Name: Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
• Applicant: Brosmed Medical Co., Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 13, 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

Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters are over-the-wire (OTW) peripheral angioplasty devices. Input: manual inflation via side leg port; guide wire insertion via straight entry port. Operation: coaxial double-lumen catheter with non-compliant nylon balloon at distal tip; balloon expands to known diameter at specific pressures (12 atm nominal; 18-22 atm rated burst). Output: mechanical dilation of arterial stenoses or post-stent expansion. Used in clinical settings by physicians. Radiopaque markers aid in positioning relative to stenosis. Benefits: restores vessel patency; improves blood flow in peripheral vasculature and dialysis fistulae.

Clinical Evidence

Bench testing only. No clinical data. 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, 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

Coaxial double-lumen catheter; non-compliant nylon balloon material; radiopaque marker bands. Dimensions: 70-150cm shaft length; 2.0-10.0mm balloon diameter; 10-150mm balloon length. Guide wire compatibility: 0.014", 0.018", or 0.035". Energy source: manual hydraulic inflation. Sterilization: not specified. Connectivity: none (mechanical device).

Indications for Use

Indicated for patients requiring dilation of stenotic lesions in iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and post-deployment stent dilatation in the 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 TM Balloon Dilatation Catheter (K103751)

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 13, 2016

BrosMed Medical Co., Ltd. Ms. Tina Yin Regulatory Affairs Manager 15th Bldg., SMEs Venture Park Songshan Lake Hi-Tech Industrial Development Zone Dongguan 523808, China

Re: K160941

Trade/Device Name: Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 31, 2016 Received: November 3, 2016

Dear Ms. Yin:

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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## Indications for Use

510(k) Number (if known) K160941

Device Name Castor NC PTA Balloon Dilatation Catheter Achilles NC PTA Balloon Dilatation Catheter Hermes NC PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The balloon dilatation catheter is intended to dilate stenoral, 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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <table><tr><td><span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr></table> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <table><tr><td><span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size: 10pt;"> <span style="font-family: Wingdings;">☐</span> </span> 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: | Tina Yin |
| Date Prepared | December 2, 2016 |
| Trade Name: | Castor NC PTA Balloon Dilatation Catheter<br>Achilles NC PTA Balloon Dilatation Catheter<br>Hermes NC 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 TM Balloon Dilatation Catheter (K103751; cleared March 22, 2011) |
| Device Description: | The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter<br>family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC<br>(0.035") PTA balloon catheter. The PTA (OTW type) device is an over the<br>wire (OTW) peripheral balloon catheter, specially designed for Percutaneous<br>Transluminal Angioplasty (PTA). The catheter working length is 70, 90 and<br>150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work<br>length range from 10mm to 150mm. The three PTA balloon dilatation<br>catheters are filed in one 510(k) submission due to the similar/equivalent<br>construction and identical material of the products. The comparison of them<br>was summarized in Table 1. The differences only exist in the guide wire<br>compatibility and the balloon configuration which have been controlled by the<br>Design Verification. The balloon material is made of a non-compliant Nylon<br>material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22<br>atmospheres. It is a coaxial double lumen catheter with a balloon located near<br>the distal tip. One lumen is used for inflation of the balloon and accessed via<br>the side leg port. The second lumen, starting at the straight entry port, allows<br>access to the distal tip of the catheter for guide wire insertion. The three<br>products of the non-compliant PTA (OTW type) balloon catheter family have<br>different diameter of the guide wire port from max.0.014" to 0.035". The<br>guide wire compatibility was shown in table 1. The balloon has radiopaque<br>markers for positioning the balloon relative to the stenosis. The radiopaque<br>marker bands indicate the dilating section of the balloon and aid in balloon<br>placement. The balloon is dilated using the side leg port, at which the balloon<br>material expands to a known diameter at specific pressure. The working<br>pressure range for the balloon is between the nominal size pressure and the<br>rated burst pressure. All balloons distend to sizes above the nominal size at<br>pressures greater than the nominal pressure. The design of this dilatation |

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| | | catheter does not incorporate a lumen for distal dye injections or distal | | | | |
|------------------------|--|---------------------------------------------------------------------------|--|--|--|--|
| pressure measurements. | | | | | | |

- 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.
- Comparisons of the new and predicate devices show that the technological Technological Characteristics: characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
- 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 stents) and also biocompatibility tests, such as cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genototocity (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 a determination of substantial equivalence between the PTA balloon dilatation catheter and the predicate devices described above.

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| | Castor NC 0.014 | Achilles NC 0.018 | Hermes NC 0.035 | Difference | Control<br>Method |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------|
| Device | catheter, angioplasty,<br>peripheral, transluminal | catheter, angioplasty,<br>peripheral, transluminal | catheter, angioplasty,<br>peripheral, transluminal | Identical | |
| Regulation<br>Description | Percutaneous catheter. | Percutaneous catheter. | Percutaneous catheter. | Identical | |
| Regulation Medical<br>Specialty | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Product Code | LIT | LIT | LIT | Identical | |
| | Office of Device Evaluation<br>6(ODE) | Office of Device Evaluation<br>6(ODE) | Office of Device Evaluation<br>6(ODE) | Identical | n/a |
| Premarket Review | Division of Cardiovascular<br>Devices (DCD) | Division of Cardiovascular<br>Devices (DCD) | 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 Number | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Identical | |
| Device Class | 2 | 2 | 2 | Identical | |
| Indications for Use | The PTA balloon dilatation<br>catheter is indicated for:<br>• dilating stenoses in the<br>iliac, femoral, iliofemoral,<br>popliteal, infrapopliteal, and<br>renal arteries, and for the<br>treatment of obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis<br>fistulae.<br>• stent dilatation<br>post-deployment in the<br>peripheral vasculature. | The PTA balloon dilatation<br>catheter is indicated for:<br>• dilating stenoses in the<br>iliac, femoral, iliofemoral,<br>popliteal, infrapopliteal, and<br>renal arteries, and for the<br>treatment of obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis<br>fistulae.<br>• stent dilatation<br>post-deployment in the<br>peripheral vasculature. | The PTA balloon dilatation<br>catheter is indicated for:<br>• dilating stenoses in the<br>iliac, femoral, iliofemoral,<br>popliteal, infrapopliteal, and<br>renal arteries, and for the<br>treatment of obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis<br>fistulae.<br>• stent dilatation<br>post-deployment in the<br>peripheral vasculature. | Identical | IFU |
| Balloon<br>Characteristic | non-compliant | non-compliant | non-compliant | Identical | Design<br>Verification;<br>labeling |
| Nominal<br>Pressure (Nom) | 12atm | 12atm | 12atm | Identical | Design<br>Verification;<br>labeling |
| Rated Burst<br>Pressure (RBP) | 18, 20, 22atm | 18, 20, 22atm | 18, 20, 22atm | 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 | 2.0-8.0mm | 2.0-8.0mm | 3.0-10.0mm | Different | Design<br>Verification:<br>labeling |
| Balloon Length | 10-150mm | 10-150mm | 20-150mm | Different | Design<br>Verification:<br>labeling |
| Shaft Length | 70, 90, 150 | 70, 90, 150 | 70, 90, 150 | Identical | Design<br>Verification:<br>labeling |

Table 1, BrosMed PTA Balloon Dilatation Catheter Comparison Table