MAMBA and MAMBA Flex Microcatheters

K190401 · Boston Scientific Corporation · DQY · Mar 15, 2019 · Cardiovascular

Device Facts

• Record ID: K190401
• Device Name: MAMBA and MAMBA Flex Microcatheters
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 15, 2019
• Decision: SESE
• Submission Type: Special
• 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; hydrophilic coating on distal portion for advancement; radiopaque marker at distal tip for visualization. Used by physicians in clinical settings. Operator advances catheter over guidewire to target lesion; provides support for wire placement; enables exchange of wires; allows injection of contrast media via proximal luer hub. Benefits include improved access to difficult coronary lesions and procedural efficiency.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical bench testing. Performance criteria evaluated: dimensional requirements, delivery/retraction, wire movement, shaft/manifold torque, wire lumen burst, tip bond, guidewire exchange, shaft flex/kink, and dye flow. Results demonstrate device meets requirements for intended use.

Technological Characteristics

Percutaneous catheter; coil-reinforced shaft; hydrophilic distal coating; radiopaque distal marker; proximal luer hub. Compatible with 0.014 in. guidewires. Available in 135cm and 150cm lengths. Sterilized device. No software or electronic components.

Indications for Use

Indicated for patients requiring additional guidewire support to reach lesions in the coronary vasculature, facilitating guidewire placement, guidewire exchange, and delivery of contrast media.

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

• MAMBA and MAMBA Flex Microcatheters (K171452)

Reference Devices

• Acuity Pro Guide catheter (K171612)

Submission Summary (Full Text)

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March 15, 2019

Boston Scientific Corporation Kevin Catalano Sr. Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311

Re: K190401

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: February 15, 2019 Received: February 19, 2019

# Dear Kevin Catalano:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from Lydia S. Glaw -S. The date of the signature is 2019.03.15, and the time is 16:24:23 -04'00'.

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) K190401

Device Name

MAMBA and MAMBA Flex Microcatheters

Indications for Use (Describe)

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.

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

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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 | Kevin Catalano<br>Three Scimed Place<br>Maple Grove, MN 55311-1566<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Prepared | 15 February 2019 |
| Proprietary Name | MAMBA™ and MAMBA™ Flex<br>Microcatheters |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate Device | MAMBA™ and MAMBA™ Flex<br>Microcatheters<br>K171452 (21 Aug 2017) |
| Reference Device | Acuity Pro Guide catheter<br>K171612 (30 Jun 2017) |

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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 quidewires 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 design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate, MAMBA Microcatheters, K171452.

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# Non-clinical Performance Data

Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data.

# Bench Testing:

Bench testing was performed to evaluate physical integrity, functionality and performance of the MAMBA Microcatheters. Performance criteria includes: dimensional requirements, delivery and retraction, wire movement, shaft and manifold torque, wire lumen burst, tip bond, guidewire exchange, shaft flex and shaft kink, and dye flow.

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 is considered to be substantially equivalent to the predicate device.

## Conclusion

Based on the indications for use, technological characteristics, performance testing, the MAMBA Microcatheters have been shown to be appropriate for their intended use and are considered to be substantially equivalent to MAMBA Microcatheters, K171452.