(14 days)
The NMI Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.
The NMI MCs has an outside diameter of 2.8F and 2.4F and has a nominal inside diameter of 0.027" and 0.021", respectively, along the entire catheter length. The MC has a braided reinforced shaft, which transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located I mm from the distal end of the catheter to identify the location of the distal tip under fluoroscopic visualization. The MC has a hydrophilic coating applied to the outer surface of the distal end. The proximal end of the MC contains a Luer fitting and strain relief. The device is provided sterile and intended for single procedure use.
This document discusses a 510(k) submission for a microcatheter. However, it explicitly states that the submission is for a labeling change only, and no design, dimensional, or material changes have been made to the predicate device.
Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance. It only mentions infusate compatibility testing supporting the labeling change, which is not a performance study as typically understood for AI/ML devices.
Based on the provided text, I cannot complete the requested tables and sections because there is no detailed performance study or acceptance criteria information for the device itself.
Here's a breakdown of why each requested section cannot be fulfilled from the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document is about a labeling change, not a new device or a change requiring re-evaluation of performance against acceptance criteria.
- Sample size used for the test set and the data provenance: Not available. There is no test set or performance data mentioned for the device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth or expert review is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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. This device is a microcatheter, not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
- The sample size for the training set: Not applicable. This is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Conclusion from the document:
The purpose of this 510(k) submission (K121954) is solely a labeling change for the NMI MC Microcatheter. The device itself is identical to previously cleared predicate devices (K112124 and K111368) in terms of intended use, materials, design, components, and technological characteristics. The performance data mentioned refers to "infusate compatibility testing" which supported the labeling change and demonstrated substantial equivalence, but this is not a study assessing the clinical performance or accuracy of the device in the way an AI/ML device would be evaluated.
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K12 1954 page 1 of 1
JUL 1 7 2012
510(k) SUMMARY
Date Prepared: July 2, 2012
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Wanda Carpinella Director, Global Regulatory Affairs 508-650-7929
C. Device Name
Trade Name: Common/Usual name: Classification Name:
Lorraine M. Hanley Vice President, Global Regulatory Affairs 508-608-7945
NMI MC Microcatheter Diagnostic Intravascular Catheter 21 CRF §870.1200, ProCode DQO Class II
Classification
D. Predicate Device(s)
The NMI MC described in this submission is identical in terms of intended use, materials, design, components and technological characteristics to the predicate NMI MC cleared under K 112124 and K111368. The change involves a labeling change only.
E. Device Description
The NMI MCs has an outside diameter of 2.8F and 2.4F and has a nominal inside diameter of 0.027" and 0.021", respectively, along the entire catheter length. The MC has a braided reinforced shaft, which transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located I mm from the distal end of the catheter to identify the location of the distal tip under fluoroscopic visualization. The MC has a hydrophilic coating applied to the outer surface of the distal end. The proximal end of the MC contains a Luer fitting and strain relief. The device is provided sterile and intended for single procedure use.
F. Intended Use
The NMI MC is intended for use in small vessels and supreselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products delivered through the microcatheter must be used in accordance with the original manufacturer's instruction for use. The catheter is not intended for use in coronary or neuro- vasculature.
G. Technology Characteristics
The proposed device is identical in terms of materials, design, and technological characteristics as the currently marketed NMI MC.
H. Performance Data
The results of infusate compatibility testing support the labeling change described in this submission and demonstrate substantial equivalence of the proposed device.
。 Conclusion
The submission is for a labeling change only. No design, dimensional or material changes have been made to the predicate device. The results of the non-clinical testing support the labeling change described in this submission demonstrate substantial equivalence of the proposed device.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 7 2012
Navylist Medical, Inc. c/o Ms. Wanda Carpinella 26 Forest St. Marlborough, MA 01752
Re: K121954
Trade/Device Name: Embarc Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: July 2, 2012 Received: July 3, 2012
Dear Ms. Carpinella:
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
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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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please . note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Cm. A. Holben
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): K 121959
Device Name: NMI Microcatheter
Indication For Use:
The NMI Microcatheter is intended for use in small vessels and superselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products must be used in accordance with the original manufacturer's instructions for use. The catheter is not intended for use in coronary or neuro- vasculature.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. G. Killian
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number 121954
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).