(24 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the microcatheters, with no mention of AI or ML capabilities.
No
The device is described as assisting in the placement of guidewires and delivery of contrast media, and delivering therapeutic agents, but it is not itself a therapeutic agent or device. It facilitates the delivery of other agents.
No
This device is a microcatheter designed to assist in the placement and exchange of guidewires, and delivery of contrast media or therapeutic agents, not for diagnosing a condition. Its function is interventional, not diagnostic.
No
The device description clearly details physical components such as a catheter shaft, coil, distal tip, and luer hub, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of guidewires, exchange guidewires, and assist in the delivery of contrast media within the coronary vasculature. This is an in vivo application, meaning it is used inside a living organism.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for interventional procedures.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Kevin Catalano
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2413
Fax: 763-494-2222
e-mail: kevin.catalano@bsci.com |
| Prepared | 15 February 2019 |
| Proprietary Name | MAMBA™ and MAMBA™ Flex
Microcatheters |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate Device | MAMBA™ and MAMBA™ Flex
Microcatheters
K171452 (21 Aug 2017) |
| Reference Device | Acuity Pro Guide catheter
K171612 (30 Jun 2017) |
4
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.
5
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.