CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

K062168 · Nemoto Kyorindo Co., Ltd. · DXT · Aug 18, 2006 · Cardiovascular

Device Facts

• Record ID: K062168
• Device Name: CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA
• Applicant: Nemoto Kyorindo Co., Ltd.
• Product Code: DXT · Cardiovascular
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Contrast Delivery System – Dual Shot Alpha is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).

Device Story

Dual Shot Alpha is an electromechanical angiographic injector used in CT suites by physicians and radiologic technologists. It features two motor-driven actuators for delivering contrast media and saline through syringes connected to intravascular catheters. The system comprises an injector head, a console with a TFT LCD touch panel, and a floor-based power supply. Operators set injection parameters—pressure, volume, flow rate, and timing—via the console. The device provides automated delivery, multi-phase injection protocols (up to 5 phases), and real-time monitoring of injection status and pressure. A remote hand switch allows for manual start/stop control. By automating contrast delivery, the device ensures precise, reproducible administration, facilitating high-quality diagnostic imaging while allowing the operator to remain at a safe distance from the X-ray source.

Clinical Evidence

Bench testing only. The device was tested for conformance to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-1-4. No clinical data was required or provided.

Technological Characteristics

Electromechanical injector; dual-syringe configuration; motor-driven actuators. Components: Injector head, console (TFT LCD touch panel), power supply. Connectivity: Hand switch interface. Software-controlled with multi-layered safety stop mechanisms. Standards: IEC 60601-1 (safety), IEC 60601-1-1 (systems), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable systems), ISO 14971 (risk management).

Indications for Use

Indicated for patients undergoing computed X-ray tomography (CT) requiring administration of ionic or non-ionic contrast media and saline via intravascular injection.

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

• DUAL SHOT - CONTRAST DELIVERY SYSTEM (K052633)

Submission Summary (Full Text)

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K062168
p. 1 of 4

AUG 1 8 2006

## 510(k) SUMMARY NEMOTO KYORINDO DUAL SHOT - CONTRAST DELIVERY SYSTEM

DATE 510(k) SUMMARY PREPARED: March 24, 2006

| OFFICIAL CONTACT: | Toshio Kanetaka<br>Director of Technical Center<br>Nemoto Kyorindo CO., LTD.<br>2-12-4 Aoki Kawaguchi-shi<br>Saitama 332-0031, Japan<br>TEL : [phone]<br>FAX : [phone] |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME(S): | Angiographic Injector with Syringe |
| DEVICE CLASSIFICATION: | Class II |

COMMON NAME: Powered Injector with Syringe

PROPRIETARY NAME:

PREDICATE DEVICE:

DUAL SHOT -- CONTRAST DELIVERY SYSTEM from NEMOTO KYORINDO K052633

Contrast Delivery System - Dual Shot Alpha

INTENDED USE:

The Contrast Delivery System – Dual Shot Alpha is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT). .

#### DESCRIPTION OF DEVICE:

Contrast Delivery System -- Dual Shot Alpha is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-siice CT scanners. The Dual Shot Alpha has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 100mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. Dual Shot Alpha consists following components;

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#### Injector head

-

Injector head provides accurate, automatic delivery of contrast media by two electromechanically driven actuators. Sterile empty-syringes or pre-filled syringes can be set onto the Injector head. For the sterile empty-syringes, Injector head provides auto-return function to fill the syringe with contrast media or saline. Injector head is composed of operation indicator LED, switches for manual operation, start-switch to start influsion and stop-switch to stop infusion. Injector head detects injection conditions and transmits the Injector head status information to the console,

- Console
The console takes up very little space on a control desk, and consists of TFT LCD display and touch panel interface to setIdisplay various injections set by an operator. The operator can set injection pressure, time, volume, flow rate and a patient examination region of interest.

- -Power Supply
The power supply is intended for placement on the floor around the console of a CT scanner. The power supply consists of a transformer and appliance inlet, as a provide power source to the injector head and console.

- Options
- ロ Hand Switch

Hand Switch is connected to the console and consists of start and stop switches to start/stop injection according to the protocols already set on the console. Hand Switch provides LEDs with an operator to display scan time and injection state.

### SUBSTANTIAL EQUIVALENCE:

Contrast Delivery System - Dual Shot Alpha maintains the same intended use as the predicate device. It is intended for the specific purpose of injecting contrast media and saline solution into a patient's vascular system to obtain diagnostic images in X ray computed tomography (i.e. "CT").

Contrast Delivery System -- Dual Shot Alpha consists of three main components like the predicate device: a Injector head, a Console, and a Power Supply. Both the Dual Shot Alpha and predicate device consist of the same or substantially equivalent materials and technology. They are motor driven, electromechanical devices that are controllect by software.

Below is a table that compares the predicate device to the proposed Contrast Delivery System - Dual Shot Alpha.

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# K062168 p. 3 = fy

.

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| Feature | Proposed Device:<br>Contrast Delivery System -<br>Dual Shot Alpha | Predicate Device:<br>DUAL SHOT - CONTRAST DELIVERY<br>SYSTEM |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use | The Contrast Delivery System - Dual Shot<br>Alpha is an intravascular injection system<br>intended for the administration of ionic and<br>non-ionic contrast media and saline used<br>in conjunction with computed x-ray<br>tomography (CT). | same |
| Single or Dual Syringe<br>System | Dual syringe model | Same |
| Information Display | Color LCD | Same |
| Programming Keys | Non-dedicated keys - software determined | Same |
| Touch Screen | Yes | Same |
| Multi-Phase | 1-5 Phases per injection | Same |
| Arming Modes | Single | Same |
| Protocol Storage | 125 protocols | Same |
| Capability | | |
| Hold Capability | Until user operate. | Same |
| Scan Delay | 1 - 300 seconds | Same |
| Safety Stop Mechanism | Multi layered software stops with backup<br>monitoring. | Same |
| Syringe System | A-head: 200mL or 100mL syringe<br>B-head: 100mL syringe | A-head: 200mL or 100mL syringe<br>B-head: 50mL syringe |
| Programmed Volume | A-head: 1 to 200mL or 1 to 100mL<br>(depending on syringe size)<br>B-head: 1 to 100mL | A-head: 1 to 200mL or 1 to 100mL<br>(depending on syringe size)<br>B-head: 1 to 50mL |
| Volume Remaining<br>Readout | Graphic and numeric on LCD | Same |
| Fill Rate | Variable<br>up to 10mL /sec | Same |
| Flow Rate | 0.1mL/sec to 10mL/sec | Same |
| Programmable Pressure<br>Limit | Settable<br>from 10 to 300PSI | Same |
| Pause | Programmable -<br>1 sec to 300 seconds<br>in 1sec increments | Same |
| Autofill | Fill rate 1.5mL/sec | Same |
| Retract Control | No | Same |
| Remote Start Switch | Yes | Same |
| Pressure Graph | Yes | Same |
| Syringe Sensing | Yes | Same |
| Test Injection | Yes | Same |
| Syringe Heat Maintainer | Yes | Same |

.

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## PERFORMANCE DATA:

No performance standards have been established for Angiographic injectors under section 514 of the FD&C Act.

Contrast Delivery System - Dual Shot Alpha has been tested in conformance with the following recognized standards, and is substantially equivalent to the predicate device:

IEC60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety - This is the general standard for medical electrical equipment IEC60601-1-1 (2000) Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC60601-1-2 (2001) Medical electrical equipment - Part 1 -- 2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests IEC60601-1-4 (1996) Medical electrical equipment -- Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems ISO13485 (2003) Medical devices - Quality management systems - Requirements for regulatory purposes ISO14971 (2000) Medical devices - Application of risk management to medical devices

Biocompatibility testing has not been performed since Contrast Delivery System - Duar Shot Alpha does not include a sterile syringe.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2006

TUV Rheinland of North America, Inc. c/o Ms. Tamas Borsai 12 Commerce Road Newton, CT 06470

Re: K062168

Contrast Delivery System - Dual Shot Alpha Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: DXT Dated: July 26, 2006 Received: July 31, 2006

Dear Ms. Borsai:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Tamas Borsai

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

FOR

Sincerely vours.

Q.B.Me

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Attachment 1b Page 1 of 1

510(k) Number (if known): Kolo2 168

Contrast Delivery System - Dual Shot Alpha Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Contrast Delivery System – Dual Shot Alpha is an intravascular injection system The Contrast Delivery System - Dual Choc films is and non-ionic contrast media and saline used in
intended for the administration of ionic and non-ionic contrast media and sa conjunction with computed X-Ray tomography (CT).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 6062168

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