(511 days)
Not Found
No
The description focuses on the mechanical and control aspects of an auto-injector system, with no mention of AI or ML capabilities for image analysis, protocol optimization, or other functions.
No.
The device is used for administering contrast media for diagnostic purposes (imaging), not for treating a disease or condition.
No
The device is an injector system for administering contrast media, which aids in diagnostic imaging but is not itself a diagnostic device.
No
The device description clearly states it is an "auto injector system" composed of "three main components: the master control and display unit, the injector head and a remote Control unit," indicating significant hardware components beyond just software.
Based on the provided information, the 3S INJECTOR - CT is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the administration of contrast media into patients for diagnostic x-ray studies (specifically CT). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The device is an injection system designed to deliver substances into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The 3S INJECTOR - CT does not perform any analysis or testing on such specimens.
Therefore, the 3S INJECTOR - CT is a medical device used for the administration of substances during an imaging procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3S INJECTOR - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT).
The 3S INJECTOR - CT is intended for the administration of contrast media into patients for diagnostic x-ray studies.
Product codes
DXT
Device Description
The Nemoto 3S Injector- CT is an auto injector system developed to meet the needs of physicians and provide accurate and steady injection rate, time, volume and enhanced safety. The 3S Injector - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT).
The Injector system is composed of three main components: the master control and display unit, the injector head and a remote Control unit. The Iniector's master control unit uses function kevs and can store up to 20 protocols. The 3S INJECTOR - CT is designed for single- use, disposable svringes of 100ml and 200ml. The single-use svringes are manufactured of polypropylene, have the same intended use and perform similarly to those of predicate devices. A complete description of the Nemoto 3S Iniector - CT is provided by the labeling information in Exhibit B.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed x-ray tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Laboratory testing reqarding the performance of the Nemoto 3S Injector- CT has been conducted to verify its safety, function and electromagnetic compatibility. A biocompatibility assessment was performed on syringe materials following international standards with satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K880493, K924116, K912944, K864227
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
510(k) SUMMARY NEMOTO 3S INJECTOR- CT CONTRAST DELIVERY SYSTEM
Submitter Information:
Prepared by: Eduardo March Senior Consultant AAC Consulting Group, Inc. 7475 Wisconsin Ave., Suite 850 Bethesda, MD 20814 Teleph .- 301-986-4440 Fax- 301-986-4448
Date 510(k) Summary Prepared: 20 October 1998
Name of the Device:
| Common Name: | Angiographic Injector with syringe |
|---|---|
| Proprietary Name: | 3S Injector - CT Contrast Delivery System |
Legally marketed devices of equivalence:
The Nemoto 3S Injector - CT is substantially equivalent to other injectors currently marketed and indicated for use with radiopaque contrast media and CT imaging systems currently on the market. Below is a listing of equivalent predicate products:
- Medrad MCT (K880493) and MCT Plus (K924116) manufactured by . Medrad
- CT 9000 Injector (K912944) manufactured by Liebel-Flarsheim Co. .
- PercuPump 1A (K864227) manufactured by E-Z-EM Inc. .
Description of Device:
The Nemoto 3S Injector- CT is an auto injector system developed to meet the needs of physicians and provide accurate and steady injection rate, time, volume and enhanced safety. The 3S Injector - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT).
The Injector system is composed of three main components: the master control and display unit, the injector head and a remote Control unit. The
1
Iniector's master control unit uses function kevs and can store up to 20 protocols. The 3S INJECTOR - CT is designed for single- use, disposable svringes of 100ml and 200ml. The single-use svringes are manufactured of polypropylene, have the same intended use and perform similarly to those of predicate devices. A complete description of the Nemoto 3S Iniector - CT is provided by the labeling information in Exhibit B.
Intended Use:
The 3S INJECTOR - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT).
Technological Characteristics:
Unimachs Corp. believes the Nemoto 3S Injector- CT is substantially equivalent to the currently marketed angiographic systems use for delivery of contrast media. The attached table compares the technical characteristics of these products.
Laboratory testing reqarding the performance of the Nemoto 3S Injector- CT has been conducted to verify its safety, function and electromagnetic compatibility. A biocompatibility assessment was performed on syringe materials following international standards with satisfactory results.
The 100 and 200 ml syringes will be sterilized using ethylene oxide gas.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2000
Mr. Eduardo March Senior Consultant AAC Consulting Group, Inc. C/O Unimachs Corporation 7475 Wisconsin Ave., Suite 850 Bethesda, MD 20814
Re : K983826 3S Injector-CT Contrast Delivery System Trade Name: Regulatory Class: II (two) Product Code: DXT February 18, 2000 Dated: Received: February 18, 2000
Dear Mr. March:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
MAR 2 3 2000
Page 2 - Mr. Eduardo March
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christopher
James E. Dillard Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of 1 -Page 1
510(k) Number (if known): K983826
NEMOTO 3S INJECTOR - CT CONTRAST Device Name: DELIVERY SYSTEM
Indications for Use:
tions for USe.
The 3S INJECTOR - CT is intended for the administration of contrast media into patients for diagnostic x-ray studies.
(Please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: / (Per 21 CFR 80.109)
OR
Over-the-Counter Use:
Clinton M. Huffman Dillard
(Division Sign-Off)
- Vision organ Organ Groupascular, Respiratory, ി Neumogical Devices
CONFIDEN
- Number _