(96 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No
The device is described as a microcatheter intended to facilitate guidewire placement, exchange guidewires, and assist in the delivery of contrast media. While it mentions the ability to "deliver ... therapeutic agents," its primary function described is supportive for diagnostic and interventional procedures, not as a therapeutic agent itself or to directly treat a condition. It facilitates the delivery of therapeutic agents, but is not therapeutic on its own.
No
The device is a microcatheter intended to facilitate the placement of guidewires, exchange guidewires, and assist in the delivery of contrast media or therapeutic agents. It is an interventional or delivery device, not one that is used to diagnose a medical condition.
No
The device description clearly outlines physical components such as a catheter shaft, coil, distal tip, luer hub, and hydrophilic coating, 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 describes a device used within the body (in vivo) to facilitate guidewire placement, exchange, and delivery of contrast media and therapeutic agents into the coronary vasculature.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Anatomical Site: The specified anatomical site is the coronary vasculature, which is inside the body.
- 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 treatment.
IVD devices are used outside the body to analyze 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 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.
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)
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.
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
510(k) Summary
per 21 CFR §807.92
| Sponsor: | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Sherry Kollmann
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-1111
Fax: 763-494-2981
e-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 Microcatheter
K140329 (15 May, 2014) |
1
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.
2
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.
3
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
4
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
5
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