(24 days)
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.
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.
The provided text is a 510(k) Premarket Notification from the FDA regarding the Boston Scientific MAMBA and MAMBA Flex Microcatheters. This document specifically focuses on the substantial equivalence of these microcatheters to a legally marketed predicate device (MAMBA Microcatheters, K171452).
The information provided does not describe a study proving the device meets acceptance criteria in the context of an AI/ML medical device, particularly one involving ground truth derived from expert consensus, pathology, or outcomes data. It also does not involve human readers, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This document is for a physical medical device (microcatheter), not a software or AI-driven diagnostic tool.
Therefore, many of the requested categories are not applicable to the content provided. I will fill in the relevant information based on the document's content, and specify "Not Applicable" or explain why the information isn't present for the other categories.
Acceptance Criteria and Device Performance for MAMBA and MAMBA Flex Microcatheters
The FDA 510(k) summary for the Boston Scientific MAMBA and MAMBA Flex Microcatheters describes non-clinical performance data to establish substantial equivalence to a predicate device. The "acceptance criteria" here refer to the performance benchmarks that the new device had to meet during bench testing to demonstrate that it is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Category of Test) | Reported Device Performance |
|---|---|
| Dimensional requirements | Met requirements |
| Delivery and retraction | Met requirements |
| Wire movement | Met requirements |
| Shaft and manifold torque | Met requirements |
| Wire lumen burst | Met requirements |
| Tip bond | Met requirements |
| Guidewire exchange | Met requirements |
| Shaft flex | Met requirements |
| Shaft kink | Met requirements |
| Dye flow | Met requirements |
Note: The document states "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" and "No new safety or performance issues were raised during the testing." While specific numerical performance values are not provided in this summary, the implication is that the new device met the pre-defined acceptance thresholds for each test.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units or tests performed for each bench test. It generically states "Bench testing was performed."
- Data Provenance: The data is from non-clinical bench testing conducted by Boston Scientific Corporation. The country of origin for the testing is not specified, but the company is U.S.-based. This is retrospective data in the sense that it was conducted prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is a physical medical device. The "ground truth" and "performance" are established through engineering specifications, material science, and mechanical bench testing, not through expert human review of diagnostic images or clinical outcomes in the same way an AI/ML device would be evaluated. The "experts" involved would be engineers, QA personnel, and potentially biomaterials scientists.
4. Adjudication Method for the Test Set
- Not Applicable. As described above, this is about physical device performance rather than interpretation or classification that would require adjudication among multiple human reviewers. Test results are likely objectively measured (e.g., burst pressure, force to kink).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study (MRMC) is relevant for diagnostic imaging AI/ML devices where the AI assists human readers. This document describes a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Not Applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering specifications, material properties, and pre-defined performance thresholds for physical and mechanical characteristics (e.g., dimensional accuracy, burst strength, flexibility, torqueability, guidewire exchange efficiency). It is based on objective, quantifiable measures of the device's physical attributes and functional capabilities as designed and manufactured.
8. The Sample Size for the Training Set
- Not Applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device largely refers to its design, material selection, and manufacturing processes, which are informed by engineering principles and previous device experience.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no "training set" in the context of an AI/ML algorithm for this physical device. The design and development of the microcatheters are based on established engineering principles, industry standards for medical devices, and performance requirements derived from extensive experience with similar predicate devices. The "ground truth" in this context would be the successful performance of existing, legally marketed devices that serve as benchmarks.
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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 (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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA |
|---|---|
| Contact Name andInformation | Kevin CatalanoThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2413Fax: 763-494-2222e-mail: kevin.catalano@bsci.com |
| Prepared | 15 February 2019 |
| Proprietary Name | MAMBA™ and MAMBA™ FlexMicrocatheters |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate Device | MAMBA™ and MAMBA™ FlexMicrocathetersK171452 (21 Aug 2017) |
| Reference Device | Acuity Pro Guide catheterK171612 (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.
§ 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).