NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML

K113198 · Navilyst Medical, Inc. · DXT · Nov 28, 2011 · Cardiovascular

Device Facts

• Record ID: K113198
• Device Name: NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
• Applicant: Navilyst Medical, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Nov 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

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

Device Story

NMI Control Syringe is a manual, piston-type syringe designed for administration of radiographic contrast media. Device features clear, calibrated hollow barrel (7 mL or 8 mL capacity) with bilateral external finger rings and proximal thumb ring; enables single-handed aspiration and expulsion of fluids. Used in clinical settings by healthcare professionals for contrast delivery. Device provides controlled fluid administration, facilitating diagnostic imaging procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluation conducted per risk analysis and international standards including ISO 7886-1, ISO 594-2, ISO 10993-1, and FDA guidance for piston syringes. Testing confirmed compliance with specifications for nozzle alignment, leakage, piston forces, dead space, and extractable metals.

Technological Characteristics

Manual piston-type syringe; 7 mL or 8 mL volume. Materials evaluated per ISO 10993-1. Features Luer taper fittings (ISO 594-2). Sterilization via ethylene oxide (ANSI/AAMI/ISO 11135-1). Mechanical operation; no software or electronic components.

Indications for Use

Indicated for patients requiring intra-arterial or intravenous administration of radiographic contrast media.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• NAMIC Angiographic Control Syringe (K873955)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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(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

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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 [phone]

www.navilystmedical.com

### 510(k) Summary for the NMI Control Syringe

Or

Lorraine M. Hanley

Phone: [phone]

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: [phone]

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

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.

K873955

### F. Intended Use

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

5-4

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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 of<br>Nozzle on End of<br>Barrel | Freedom from Air<br>Leakage past<br>Piston | Lubricant<br>(Quantity) | Piston Pull Out<br>Force |
| Barrel Finger<br>Grips | Freedom from<br>Liquid Leakage<br>past Piston | Nozzle Conical<br>Fitting | Stroke Length |
| Cleanliness | Graduated Scale | Nozzle Lumen | Syringe Capacity |
| Dead Space | Length of Scale | Numbering of<br>Scale | Zero Graduation<br>and Fiducial Lin<br>Alignment |
| Fiducial Line | Limits for Acidity<br>or Alkalinity | Piston (Plunger)<br>Forces | |
| Fit of piston in<br>barrel | Limits for<br>Extractable Metals | Piston Assembly<br>Design | |

## 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.