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.

Device Description

The NMI 2.8F MC has an outside diameter of 2.8F and has a nominal inside diameter of 0.027" along the entire catheter length. The MC's shaft is a braided reinforced shaft, which transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located 1mm from the catheter's distal end to identify the location of the distal tip under fluoroscopic visualization. The distal end of the catheter's outer surface is hydrophilic coated. The proximal end of the MC contains a Luer fitting and strain relief. The device is provided sterile and intended for single procedure use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of detail as it's a labeling change submission:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this submission (K113638) is for a labeling change only and states that "The NMI 2.8F MC described in this submission is identical in terms of intended use, materials, design, components and technological characteristics to the predicate NMI 2.8F MC cleared under K112124. The change involves a labeling change only."

Therefore, the performance data presented is to demonstrate substantial equivalence to the predicate device, not necessarily against specific new acceptance criteria for the device itself. The document does not provide specific quantitative acceptance criteria or detailed results for these tests. It only lists the types of tests performed.

Test Category	Reported Device Performance
Dynamic Infusion Testing	Not specified beyond indicating the test was performed.
Static Burst Testing	Not specified beyond indicating the test was performed.
Flow Rate Testing	Not specified beyond indicating the test was performed.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the non-clinical tests (Dynamic Infusion, Static Burst, Flow Rate Testing), nor does it provide information about data provenance (e.g., country of origin of the data, retrospective or prospective). Given these are bench tests, "country of origin" for data is generally not applicable in the same way it would be for clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The "ground truth" concept is relevant for studies involving human assessment (e.g., image-based diagnosis) or clinical outcomes. The performance data presented are from non-clinical (bench) tests.

4. Adjudication Method for the Test Set

This information is not applicable. The performance data presented are from non-clinical (bench) tests, which do not involve human adjudication for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a labeling change and relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. It does not involve human readers or AI.

6. If a Standalone Study Was Done

Yes, from the perspective of the "device," the non-clinical tests (Dynamic Infusion, Static Burst, Flow Rate Testing) are essentially standalone performance evaluations of the physical characteristics of the microcatheter. However, "standalone" often implies an algorithm's performance without human intervention, which is not relevant here as this is a physical medical device. The performance data listed (Dynamic Infusion Testing, Static Burst Testing, Flow Rate Testing) represent the device’s inherent physical capabilities.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be established by validated test methods and reference standards for physical and functional properties of catheters (e.g., infusion rate, burst pressure, flow rate). These are objective measurements rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (microcatheter), not an AI or machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this device.

Summary

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K113638

Date Prepared: December 08, 2011

JAN - 5 2012

510(k) SUMMARY

Lorraine M. Hanley

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact

Wanda Carpinella Sr. Manager Global Regulatory Affairs 508-650-7929

C. Device Name

Trade Name: Common/Usual name: Classification Name:

•

Classification

D. Predicate Device(s)

Vice President, Global Regulatory Affairs 508-608-7945

NMI 2.8F MC Microcatheter Diagnostic Intravascular Catheter 21 CRF §870.1200, ProCode DQO Class II

The NMI 2.8F MC described in this submission is identical in terms of intended use, materials, design, components and technological characteristics to the predicate NMI 2.8F MC cleared under K112124. The change involves a labeling change only.

E. Device Description

F. Intended Use

The NMI Microcatheter 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 has similar materials, design and components and technological characteristics as currently marketed microcatheters.

H. Performance Data

The proposed NMI 2.8F MC is substantially equivalent to NMI's predicate 2.8F MC based on a comparison of technological characteristics and the results of non-clinical tests, which included:

. Dynamic Infusion Testing
. Static Burst Testing
· Flow Rate Testing

I. Conclusion

The submission is for a labeling change only. There has been no change to design, dimensions or materials to the predicate device. The results of the non-clinical testing support the labeling change described in this submission and demonstrate substantial equivalence of the proposed and predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three thick, curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN - 5 2012

Navylist Medical, Inc. c/o Ms. Wanda Carpinella 26 Forest St. Marlborough, MA 01752

Re: K113638

Trade/Device Name: NMI Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: December 8, 2011 Received: December 9, 2011

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.

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Page 2 - Ms. Wanda Carpinella

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/ReportalProblem/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 yours.

M. A. Hilleben

Ja 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 (1 36 78

Device Name: NMI 2.8F Microcatheter

Indication For Use:

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)

C.M. Hilleben

(Division Sign-Off) (Division of Cardiovascular Devices

113638 510(k) Number

Regulation Number and Section

§ 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).