MAMBA and MAMBA FLEX Microcatheters

K171452 · Boston Scientific Corporation · DQY · Aug 21, 2017 · Cardiovascular

Device Facts

• Record ID: K171452
• Device Name: MAMBA and MAMBA FLEX Microcatheters
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The MAMBA™ and MAMBA™ Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another. The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

Device Story

MAMBA and MAMBA Flex are percutaneous microcatheters used in coronary vasculature; provide platform for guidewire exchange without losing position; assist in delivery of contrast media and therapeutic agents. Device features inner lumen for 0.014 in. guidewires; coil-reinforced shaft for torque control; hydrophilic coating on distal portion for advancement; radiopaque marker at distal tip for visualization. Used by physicians in clinical settings. Benefits include improved wire support to reach lesions and procedural efficiency during guidewire exchange.

Clinical Evidence

No clinical data. Evidence consists of bench testing (per FDA Class II Special Controls for PTCA catheters) and animal testing to verify mechanical performance, torque response, and biocompatibility.

Technological Characteristics

Percutaneous catheter; coil-reinforced shaft; hydrophilic distal coating; radiopaque distal marker; single luer hub. Compatible with 0.014 in. guidewires. Lengths: 135cm (MAMBA/Flex) and 150cm (Flex). Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring additional wire support to reach lesions in the coronary vasculature and for the delivery of contrast media or therapeutic agents to selected sites.

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

• ASAHI Corsair Microcatheter (K151103)
• ASAHI Corsair Microcatheter (K083127)

Reference Devices

• Renegade Hi-Flo Microcatheter (K140329)

Submission Summary (Full Text)

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# 510(k) Summary
per 21 CFR §807.92

| Sponsor: | Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, Massachusetts 01752<br>USA |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Sherry Kollmann<br>Three Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Prepared | 16 May 2017 |
| Proprietary Name | MAMBA™ and MAMBA™ Flex Microcatheters |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate Device | ASAHI Corsair Microcatheter:<br>K151103 (23 June 2015)<br>K083127 (03 February 2009) |
| Reference Device | Renegade Hi-Flo Microcatheter<br>K140329 (15 May, 2014) |

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## Device Description

The MAMBA™ and MAMBA™ Flex devices (referred to as the "MAMBA Microcatheters") are designed to provide a platform for the user to exchange guidewires without losing their position in the vasculature.

The MAMBA device is available in a 135cm length, while MAMBA Flex is available in 135cm and 150cm lengths.

The MAMBA Flex models have a smaller outer diameter and a more flexible distal portion than the MAMBA device.

Marks on the proximal portion of the catheter shaft and a radiopaque marker at the distal tip facilitate placement of the device.

The device's inner lumen permits the use of 0.014 in./0.36 mm or smaller quidewires. The shaft consists of a coil which allows the device to be torqued to assist in advancement. The distal portion of the shaft is coated hydrophilic coating to assist in advancement.

The proximal end has a single luer hub for flushing or injecting through the inner lumen and is for guide wire lumen access during a guidewire exchange.

The MAMBA Microcatheters are to be used in patients where vessel conditions require additional wire support to reach the lesion and will deliver radiopaque media and therapeutic agents to selected sites in coronary vasculature.

#### Indications for Use / Intended Use

The MAMBA™ and MAMBA™ Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another.

The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

## Comparison of Technological Characteristics

The MAMBA Microcatheters incorporate substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the ASAHI Corsair Microcatheter, K151103 and K083127.

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#### Performance Data

The MAMBA Microcatheters were subjected to testing according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010 (non-balloon component tests were applicable). Bench, animal and biocompatibility testing in accordance with ISO 10993 were 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 testing; therefore, this device may be considered substantially equivalent to the predicate device.

#### Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the MAMBA Microcatheters have been shown to be appropriate for their intended use and are considered to be substantially equivalent to the Asahi Corsair Microcatheter.

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Public Health Service

Image /page/3/Picture/2 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 a stylized image of an eagle with three human profiles incorporated into its design.

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

August 21, 2017

Boston Scientific Corporation Ms. Sherry Kollmann Principal Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311

Re: K171452

Trade/Device Name: MAMBA and MAMBA Flex Microcatheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 21, 2017 Received: July 24, 2017

Dear Ms. Kollmann:

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 device

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related 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

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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