3S INJECTOR-CT CONTRAST DELIVERY SYSTEM

K983826 · Unimachs Corp. · DXT · Mar 23, 2000 · Cardiovascular

Device Facts

• Record ID: K983826
• Device Name: 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
• Applicant: Unimachs Corp.
• Product Code: DXT · Cardiovascular
• Decision Date: Mar 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

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).

Device Story

The Nemoto 3S Injector-CT is an automated intravascular injection system for delivering ionic and non-ionic contrast media during CT imaging. The system comprises a master control/display unit, an injector head, and a remote control unit. It utilizes single-use, 100ml or 200ml polypropylene syringes. The master control unit allows for the storage and execution of up to 20 injection protocols, providing controlled injection rate, time, and volume. Operated by clinical staff in a radiology setting, the device ensures accurate and steady contrast delivery to enhance diagnostic imaging. The system is designed to improve safety and precision compared to manual injection methods.

Clinical Evidence

Bench testing only. Performance verified through laboratory testing for safety, function, and electromagnetic compatibility. Biocompatibility assessment of syringe materials conducted per international standards.

Technological Characteristics

Intravascular auto-injector system. Components: master control/display unit, injector head, remote control. Syringes: 100ml/200ml polypropylene, ethylene oxide sterilized. Protocol storage: up to 20. Connectivity: not specified. Power: not specified.

Indications for Use

Indicated for the administration of contrast media into patients for diagnostic x-ray studies.

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

• Medrad MCT (K880493)
• MCT Plus (K924116)
• CT 9000 Injector (K912944)
• PercuPump 1A (K864227)

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

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)

1. Vision organ Organ Groupascular, Respiratory, ി Neumogical Devices

CONFIDEN

- Number _