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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the MAMBA™ and MAMBA™ Flex Microcatheters. It asserts substantial equivalence to a predicate device, the ASAHI Corsair Microcatheter. The provided text primarily focuses on device description, indications for use, and a general statement about performance data, but does not contain the specific details required to answer many of the questions.

Here's an analysis of what can and cannot be answered based on the provided text:

Key Takeaway: The provided 510(k) summary is for a medical device (microcatheter), not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" as applied to AI performance, "test sets," "ground truth establishment," "MRMC studies," or "standalone algorithm performance" (questions 1, 2, 3, 4, 5, 6, 7, 8, 9) does not directly apply in the context of this document.

The "Performance Data" section refers to bench, animal, and biocompatibility testing typical for a physical medical device. It states that "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." However, it does not provide the specific numerical acceptance criteria or reported device performance in a table format that would be expected for an AI device.

Detailed Breakdown of Questions and Answers based on the provided text:

A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "Bench, animal and biocompatibility testing in accordance with ISO 10993 were performed to support a determination of substantial equivalence." It concludes that "No new safety or performance issues were raised during the testing; therefore, this device may be considered substantially equivalent to the predicate device." However, it does not present specific quantitative acceptance criteria or numerical reported performance data in a table format for a medical device like a microcatheter. The "acceptance criteria" for a physical device would relate to things like burst pressure, flow rate, tensile strength, kink resistance, etc., which are not detailed here.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This question is relevant to AI/SaMD. For a physical device, "sample size" would refer to the number of devices tested in bench or animal studies. While it states "Bench, animal and biocompatibility testing," it does not specify the sample sizes used for these tests or the "provenance" of such data (e.g., animal study location, if applicable).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This question is specific to AI/SaMD development, where expert consensus often establishes ground truth for image labeling or diagnosis. This document pertains to a physical medical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This question is specific to establishing ground truth with multiple readers for AI/SaMD development.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are used to evaluate the impact of AI assistance on human reader performance, typically in diagnostic imaging. This is a physical medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question refers to the performance of an AI algorithm on its own. This document is about a physical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the AI sense. For a physical device, "ground truth" would relate to objective measurements from bench testing (e.g., a force gauge measurement compared to a specification) or observations in animal studies (e.g., successful navigation, absence of vessel damage). The document only generally states that "Bench, animal and biocompatibility testing" were performed.
The sample size for the training set
- Not applicable. "Training set" refers to data used to train an AI algorithm. This is a physical medical device.
How the ground truth for the training set was established
- Not applicable. Same reasoning as above.

Summary of what the document does provide:

Device identification: MAMBA™ and MAMBA™ Flex Microcatheters.
Classification: Class II, Percutaneous Catheter (DQY).
Intended Use: Provide support for guidewire placement, facilitate guidewire exchange, assist in delivery of contrast media, and therapeutic agents in coronary vasculature.
Predicate Device: ASAHI Corsair Microcatheter (K151103, K083127).
Performance Data Overview: Mentions "Bench, animal and biocompatibility testing in accordance with ISO 10993" were performed. Concludes that no new safety or performance issues were raised and the device is substantially equivalent.
Regulatory Outcome: FDA issued a substantial equivalence letter.

In conclusion, the provided text is a standard 510(k) summary for a physical medical device, not an AI/SaMD. As such, the detailed performance and validation data typically required for AI device assessment (as reflected in most of your questions) are not present or applicable.

Summary

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510(k) Summary

per 21 CFR §807.92

Sponsor:	Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA
Contact Name andInformation	Sherry KollmannThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-1111Fax: 763-494-2981e-mail: sherry.kollmann@bsci.com
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:K151103 (23 June 2015)K083127 (03 February 2009)
Reference Device	Renegade Hi-Flo MicrocatheterK140329 (15 May, 2014)

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Device Description

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 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.

Indications for Use / Intended Use

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Regulation Number and Section

§ 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).