The NMI Control Syringes are manual control, piston type syringes consisting of a clear, calibrated, hollow barrel accommodating volumes of either 7 mL or 8 mL. As a manual control syringe, each configuration includes bilateral, external finger rings located on the proximal thumb ring, located on the piston, in tandem with the external finger rings, allows for single handed movement to create aspiration and/or expulsion of fluids.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "NMI Control Syringe." It details the device's intended use, its similarities to a predicate device, and the performance testing conducted. However, the document does not describe a study involving human readers, AI, or the establishment of ground truth by clinical experts, nor does it provide an effect size for human performance improvement with AI assistance. The device is a physical syringe, not a software or AI-driven diagnostic tool.

Therefore, many of the requested categories are not applicable to this document. I will fill in the applicable information and state when a category is not applicable based only on the provided text.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists "key tests" that were performed and states that the "successful results... demonstrate that the proposed NM1 Control Syringe met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, the exact quantitative acceptance criteria and the specific reported performance measurements for each test are not detailed in the provided text. The table only lists the types of tests performed.

Test	Acceptance Criteria	Reported Device Performance
Alignment of Nozzle on End of Barrel	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Freedom from Air Leakage past Piston	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Lubricant (Quantity)	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Piston Pull Out Force	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Barrel Finger Grips	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Freedom from Liquid Leakage past Piston	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Nozzle Conical Fitting	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Stroke Length	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Cleanliness	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Graduated Scale	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Nozzle Lumen	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Syringe Capacity	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Dead Space	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Length of Scale	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Numbering of Scale	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Zero Graduation and Fiducial Line Alignment	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Fiducial Line	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Limits for Acidity or Alkalinity	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Piston (Plunger) Forces	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Fit of piston in barrel	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Limits for Extractable Metals	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)
Piston Assembly Design	(Not specified in document)	Met pre-determined acceptance criteria (qualitative statement)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document. The document refers to "testing" and "successful results" but does not quantify the number of devices tested.
Data Provenance: Not specified in the provided document. The data would likely be from laboratory testing of the physical syringe components.

3. 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 device is a physical syringe, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in a clinical context. The "truth" for this device's performance would be objective measurements against engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This concept applies to studies where human interpreters or algorithms identify findings that require a consensus or adjudication process. For a physical device like a syringe, performance is measured against objective standards, not subject to adjudication in this manner.

5. 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. The device is a physical NMI Control Syringe, not an AI software. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. The device is a physical NMI Control Syringe, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" for the NMI Control Syringe's performance would be derived from engineering and material standards (e.g., ISO standards, FDA guidance) and objective measurements of physical properties (e.g., freedom from leakage, dimensions, forces, material compatibility). It does not involve clinical "ground truth" like pathology or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set

Not Applicable. The device is a physical syringe, not a machine learning model. There is no concept of a "training set" for the type of testing described.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for a physical device like this syringe, establishing ground truth for it is irrelevant.

Summary

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Image /page/0/Picture/1 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 its wings spread, rendered in a simple, bold line style.

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

June 8, 2017

Navilyst Medical, Incorporated Mr. Marion W. Gordon Global Regulatory Affairs Project Manager 26 Forest Street Marlborough, Massachusetts 01752

Re: K113198

Trade/Device Name: NMI Control Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector syringe Regulatory Class: II Product Code: DXT Dated: October 28, 2011 Received: October 31, 2011

Dear Mr. Gordon

This letter corrects our substantially equivalent letter of November 28, 2011.

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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Page 2 - Mr. Gordon

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 contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if Known):

Device Name:

NMI Control Syringe

-113198

Indications for Use:

The NMI Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.

Prescription Use (21 CFR 801 Subpart D) X And/Or AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

Image /page/2/Picture/9 description: The image contains a simple black square. The square is a basic geometric shape with four equal sides and four right angles. The square is solid black, with no visible texture or shading. The image is minimalist and focuses solely on the square as the central element.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

nee of CDRH, Office of Device Evaluation (ODE) neurre

(Division Sign-Off) 11/28/14

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113198

Confidential and Proprietary to Navilyst Medical, Inc.

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KII 3198

1 of 2

NOV 2 8 2011

Image /page/3/Picture/3 description: The image shows the logo for Navilyst Medical. The logo consists of a stylized image to the left of the company name. The company name is written in a bold, sans-serif font, with the word "Navilyst" on top of the word "Medical."

26 Forest Street Marlborough, MA 01752 Tel 508.658.7990

www.navilystmedical.com

510(k) Summary for the NMI Control Syringe

Lorraine M. Hanley

Phone: 508-494-1129

Global Regulatory Affairs

NMI Control Syringe

21 CFR §880.5860, Class II

Control Syringe

Piston Syringe

General Hospital

Vice President

Date prepared: 28 October 2011

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

B. Contact

A. Sponsor

Marion W. Gordon Project Manager Global Regulatory Affairs Phone: 508-658-7942

C. Device Name

Trade Name: Common/Usual name: Classification Name:

Classification Panel:

D. Predicate Device

Trade Name: Common/Usual name: Classification Name:

Premarket Notification

NAMIC Angiographic Control Syringe Control Syringe Piston Syringe 21 CFR §880.5860, Class II

E. Device Description

K873955

F. Intended Use

The NMI Control Syringe is intended to be used for the intravenous administration of radiographic contrast media.

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G. Summary of Similarities and Differences in Technological Characteristics and Performance

The proposed NMI Control Syringes have similar materials, design and components, and technological characteristics as the predicate control syringe.

H. Performance

No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. The performance evaluation of the NMI Control Syringes was conducted based upon a risk analysis and included testing conducted in accordance with the following international standards and FDA guidance document:

. ISO 7886-1, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (1993)
ISO 594-2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical . Equipment- Part 2: Lock Fittings (1998)
ANSI/AAMI/ISO I I 135-1, Sterilization of health care products Ethylene oxide Part 1 : . Requirements for development, validation and routine control of a sterilization process for medical devices (2007)
ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and tessing within a risk . management process (2009)
AAMI/ANSI/ISO Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization ● residuals (2008)
. AAMI/ANSI/ISO 11601-1 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006)
A AMI/ANSIASO 11601-2 Packaging for terminally sterilized medical devices Part 2: Validation ● requirements for forming, sealing and assembly processes (2006)
. FDA's FDA Guidance on the Content of Premarket Norification [510(k)] Submissions for Piston Syringes, dated April 1993

Safety and Performance Testing 1.

The successful results of the following key tests demonstrate that the proposed NM1 Control Syringe met the pre-determined acceptance criteria applicable to the safety and efficacy of the device.

Tests
Alignment ofNozzle on End ofBarrel	Freedom from AirLeakage pastPiston	Lubricant(Quantity)	Piston Pull OutForce
Barrel FingerGrips	Freedom fromLiquid Leakagepast Piston	Nozzle ConicalFitting	Stroke Length
Cleanliness	Graduated Scale	Nozzle Lumen	Syringe Capacity
Dead Space	Length of Scale	Numbering ofScale	Zero Graduationand Fiducial LinAlignment
Fiducial Line	Limits for Acidityor Alkalinity	Piston (Plunger)Forces
Fit of piston inbarrel	Limits forExtractable Metals	Piston AssemblyDesign

J. Conclusion

Results of performance testing according to recognized standards and in consideration to the responses posed in FDA's Guidance on the CDRH Premarket Notification Review Program, 510(k) Decision Making Tree, the proposed devices are determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.