(28 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a manual syringe, with no mention of AI or ML.
No
The device is described as being used for the administration of contrast media, which is a diagnostic rather than therapeutic function.
No
The device is described as a control syringe for administering contrast media. Its performance evaluation focuses on physical characteristics and safety for administration, not on diagnosing medical conditions.
No
The device description clearly describes a physical, manual control syringe with a barrel, piston, finger rings, and thumb ring. The performance studies also focus on physical characteristics and functionality of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intra-arterial or intravenous administration of radiographic contrast media." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe designed for manual control and fluid delivery, consistent with its intended use for administering contrast media.
- 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 specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is purely for the delivery of a substance into the body.
N/A
Intended Use / Indications for Use
The NMI Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.
Product codes
DXT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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)
- AAMI/ANSI/ISO 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
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 Nozzle on End of Barrel
Freedom from Air Leakage past Piston
Lubricant (Quantity)
Piston Pull Out Force
Barrel Finger Grips
Freedom from Liquid Leakage past Piston
Nozzle Conical Fitting
Stroke Length
Cleanliness
Graduated Scale
Nozzle Lumen
Syringe Capacity
Dead Space
Length of Scale
Numbering of Scale
Zero Graduation and Fiducial Lin Alignment
Fiducial Line
Limits for Acidity or Alkalinity
Piston (Plunger) Forces
Fit of piston in barrel
Limits for Extractable Metals
Piston Assembly Design
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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.
3
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
510(k) Summary for the NMI Control Syringe
Or
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
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.
F. Intended Use
The NMI Control Syringe is intended to be used for the intravenous administration of radiographic contrast media.
5-4
4
page 2 of 2
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 | |||
| Nozzle on End of | |||
| Barrel | Freedom from Air | ||
| Leakage past | |||
| Piston | Lubricant | ||
| (Quantity) | Piston Pull Out | ||
| Force | |||
| Barrel Finger | |||
| Grips | Freedom from | ||
| Liquid Leakage | |||
| past Piston | Nozzle Conical | ||
| Fitting | Stroke Length | ||
| Cleanliness | Graduated Scale | Nozzle Lumen | Syringe Capacity |
| Dead Space | Length of Scale | Numbering of | |
| Scale | Zero Graduation | ||
| and Fiducial Lin | |||
| Alignment | |||
| Fiducial Line | Limits for Acidity | ||
| or Alkalinity | Piston (Plunger) | ||
| Forces | |||
| Fit of piston in | |||
| barrel | Limits for | ||
| Extractable Metals | Piston Assembly | ||
| 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.