(77 days)
No
The device description is a simple piston syringe, and there are no mentions of AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The performance studies focus on standard syringe testing and equivalence to predicate piston syringes.
No
The device is used for administering contrast and saline, not for treating a disease or condition.
No
The device is described as a piston syringe intended for the administration of contrast media and saline solutions, which are used during angiographic procedures (a type of medical imaging). Its function is to deliver substances, not to diagnose conditions.
No
The device description explicitly states "Piston Syringe," which is a hardware component. The performance studies also reference standards and guidance documents related to physical syringes.
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 intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure." 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 device is described as a "Piston Syringe," which is a tool for administering fluids directly into the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of substances during a medical procedure.
N/A
Intended Use / Indications for Use
The NAMIC RCS is intended to be used for the intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.
Product codes
FMF
Device Description
The NAMIC RCS is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.
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)
The NAMIC RCS is substantially equivalent to the predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation conducted in accordance with the following FDA guidance documents, international standards, and testing which included:
- . FDA's "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes dated April 1993"
- . ISO 7886-1:1997 "Sterile Hypodernic Syringes for Single Use -- Par1 1: Syringes for Manual Use'
- . ISO 594-2:1998 "Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Other Medical Equipment - Part 2: Lock Fittings"
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Navilyst Medical. Inc. NAMIC RCS. Abbreviated 510(k) January 24, 2014
A. Sponsor
K140194
510(K) SUMMARY FOR THE NAMIC RCS
APR 1 4 2014
Date prepared: January 24, 2014
- Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752 B. Contact Brandon M. Brackett OR Wanda Carpinella Specialist, Global Regulatory Affairs Director of Global Regulatory Affairs 508-658-7984 508-658-7929 C. Device Name Trade Name NAMIC RCS Common/Usual name: Piston Syringe Classification Name: Syringe, Piston (21CFR§880.5860. Class II) Classification Panel: General Hospital D. Predicate Device(s) Common/Usual name: Piston Syringe Classification Name Syringe, Piston - 21CFR$880.5860. Class H Classification Panel: General Hospital
E. Device Description
Premarket Notification
Intended Use
The NAMIC RCS is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.
F. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed NAMIC RCS syringes incorporate similar materials, design, components, technological characteristics, and intended us as the predicate syringes.
G. Performance Data
The NAMIC RCS is substantially equivalent to the predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation conducted in accordance with the following FDA guidance documents, international standards, and testing which included:
- . FDA's "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes dated April 1993"
- . ISO 7886-1:1997 "Sterile Hypodernic Syringes for Single Use -- Par1 1: Syringes for Manual Use'
- . ISO 594-2:1998 "Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Other Medical Equipment - Part 2: Lock Fittings"
H. Conclusion
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2014
Navilyst Medical, Inc. Brandon M. Brackett Global Regulatory Affairs Specialist 26 Forest Street Marlborough, MA 01752
Re: K140194
Trade/Device Name: NAMIC RCS Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: January 24, 2014 Received: January 27, 2014
Dear Mr. Brackett:
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 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 of medical
2
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140194
Device Name NAMIC RCS
Indications for Use (Describe)
The NAMIC RCS is intended to be used for the intra-venous administration of radiographic contrast media and saline solutions during an angiographic procedure.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by Richard C. Chapman Date: 2014.04.14 08:59:45 -04'00'
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