(256 days)
No
The document describes a contrast delivery system with mechanical components and standard electrical controls, with no mention of AI or ML capabilities.
No.
The device administers contrast media and saline for diagnostic imaging purposes (CT scans) rather than directly treating a disease or medical condition.
No
This device is a contrast delivery system for administering contrast media and saline in conjunction with CT scans. It facilitates the imaging process by delivering the contrast, but it does not analyze or interpret the images to make a diagnosis.
No
The device description explicitly lists hardware components such as "Injector Powerhead" and "Console," indicating it is a physical system, not software-only.
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 administration of contrast media and saline intravascularly (into the blood vessels) for use with CT scans. This is a procedure performed on the patient, not on a sample taken from the patient.
- Device Description: The device is described as an angiographic injector used in conjunction with CT. It delivers substances directly into the patient's bloodstream.
- 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 about a physiological or pathological state, or to monitor therapeutic measures.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose or monitor conditions. This device is designed to deliver substances into the body for imaging purposes.
N/A
Intended Use / Indications for Use
The contrast delivery system Dual Shot Alpha 7 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).
Product codes
DXT
Device Description
The contrast delivery system ~ Dual Shot Alpha 7 is an angiographic injector that is used in conjunction with Computed Tomography, and is intended for use by doctors, radiology technologists and other licensed medical practitioners. This device is designed to be used in conjunction with various injection methods of contrast media and saline, and utilized with multi-slice CT scanners.
The Dual Shot Alpha 7 has two driving mechanisms to deliver contrast media and/or saline, each side A and B respectively are capable of utilizing either a 100mL or 200mL size syringe. Syringes are connected to the patient via an intravascular catheter. The Dual Shot Alpha 7 consists following components;
Injector Powerhead
The injector Powerhead is intended to provide 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 emplysyringes, the injector head provides a Quick Return function to fill the syringe with contrast media or saline. The Powerhead is composed of operation indicator LED, switches for manual operation, start-switch to start infusion and stop-switch to stop infusion. Injector head detects injection conditions and transmits the Injector head status information to the console.
Console
The new style Console, now has an integrated power supply with universal voltage input, was designed to take up very little space on a control desk, and consists of TFT LCD display and touch panel interface to set/display various injections set by an operator. The operator can set injection pressure, time, volume, flow rate and a patient examination region of interest. The Dual Shot Alpha 7 also includes as a standard item the Body Weight Protocol from our previous Dual Shot Alpha platform.
Options
Hand Switch
The 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. The Hand Switch provides LED style display to display scan time and injection state,
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
Doctors, radiology technologists and other licensed medical practitioners.
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 contrast delivery system Dual Shot Alpha 7 has been tested in conformance with the following recognized standards, and is substantially equivalent to the predicate device Dual Shot Alpha:
EN 60601-1 (2006) Medical Electrical Equipment, Part 1: General Requirements for basic Safety and essential performance
EN 60601-1-2 (2007) Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN 60601-1-6 (2010) Medical electrical equipment Part 1-6: General requirements for safety and essential performance -Collateral standard. Usability
EN 62304:2006 Medical Device Software - Software Life Cycle Processes
EN 62366:2008 Medical Devices - Application of usability engineering to medical devices
EN 1041:2008 Information supplied by the manufacturer with medical devices
EN ISO13485:2012 Medical devices - Quality management systems -Requirements for regulatory purposes
EN ISO14971:2012 Medical devices -- Application of risk management to medical devices
Biocompatibility testing has not been performed because the contrast delivery system Dual Shot Alpha 7 does not include a sterile syringe.
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
| Nemoto Kyorindo Co., Ltd. |
|---|
| 2-12-4 Aoki, Kawaguchi-shi |
| Saitama, 332-0031 |
JUN 3 0 2014 K133189
ry
Special 510k Section 011 Page 1 of 4
Special 510(k) SUMMARY CONTRAST DELIVERY SYSTEM - Dual Shot Alpha 7
DATE SUMMARY PREPARED: June 19, 2013
OFFICIAL CONTACT. Ken Wakabayashi Vice Director, Overseas Department Nemoto Kyorindo CO., LTD. 2-12-4 Aoki Kawaguchi-shi Saitama 332-0031, Japan TEL : +81 48 250 3255 FAX : +81 48 250 3256
CLASSIFICATION NAME(S): Angiographic Injector with Syringe
DEVICE CLASSIFICATION: Class II
COMMON NAME: Powered Injector with Syringe PROPRIETARY NAME: Contrast Delivery System -- Dual Shot Alpha 7
PREDICATE DEVICE:
Dual Shot Alpha- CONTRAST DELIVERY SYSTEM from NEMOTO KYORINDO K062168 and K071691
INTENDED USE:
The contrast delivery system Dual Shot Alpha 7 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:
The contrast delivery system ~ Dual Shot Alpha 7 is an angiographic injector that is used in conjunction with Computed Tomography, and is intended for use by doctors, radiology technologists and other licensed medical practitioners. This device is designed to be used in conjunction with various injection methods of contrast media and saline, and utilized with multi-slice CT scanners.
The Dual Shot Alpha 7 has two driving mechanisms to deliver contrast media and/or saline, each side A and B respectively are capable of utilizing either a 100mL or 200mL size syringe. Syringes are connected to the patient via an intravascular catheter. The Dual Shot Alpha 7 consists following components;
1
| Nemoto Kyorindo Co., Ltd. | Special 510k |
|---|---|
| 2-12-4 Aoki, Kawaguchi-shi | Section 011 |
| Saitama, 332-0031 | Page 2 of 4 |
Iniector Powerhead
The injector Powerhead is intended to provide 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 emplysyringes, the injector head provides a Quick Return function to fill the syringe with contrast media or saline. The Powerhead is composed of operation indicator LED, switches for manual operation, start-switch to start infusion and stop-switch to stop infusion. Injector head detects injection conditions and transmits the Injector head status information to the console.
Console
The new style Console, now has an integrated power supply with universal voltage input, was designed to take up very little space on a control desk, and consists of TFT LCD display and touch panel interface to set/display various injections set by an operator. The operator can set injection pressure, time, volume, flow rate and a patient examination region of interest. The Dual Shot Alpha 7 also includes as a standard item the Body Weight Protocol from our previous Dual Shot Alpha platform.
- Options .
Hand Switch
The 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. The Hand Switch provides LED style display to display scan time and injection state,
SUBSTANTIAL EQUIVALENCE:
The contrast delivery system Dual Shot Alpha 7 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").
The contrast delivery system Dual Shot Alpha 7 consists of two main components the Powerhead and Console unlike the predicate device that included an Injector head, a Console, and a Power Supply, Both the Dual Shot Alpha 7 and predicate device consist of the same or substantially equivalent materials and technology. They are motor driven, electromechanical devices that are controlled by software.
Below is a table that compares the predicate device (Dual Shot Alpha) to the proposed modified Dual Shot Alpha 7,
2
Nemoto Kyorindo Co., Ltd.
2-12-4 Aoki. Kavaguchi shi
Saitama. 332-0031
.
Special 510k Section 011
· Page 3 of 4
| Feature | Proposed Device: | Predicate Device: | |||
|---|---|---|---|---|---|
| Contrast Delivery System - | |||||
| Dual Shot Alpha 7 | Contrast Delivery System - | ||||
| Dual Shot Alpha K062168 and K071691 | |||||
| Intended Use | The contrast delivery system Dual Shot | ||||
| Alpha 7 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). | Same | ||||
| Single or Dual Syringe | |||||
| 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 | |||
| Interphase Delay | 0-300 seconds, 1 sec. increments | Same | |||
| Rise Time | Off = 0 seconds, On = 2 seconds | Same | |||
| Arming Modes | Single | Same | |||
| Protocol Storage | |||||
| Capability | 80 protocols | 125 protocols | |||
| Hold Capability | Until user operate. | Same | |||
| Scan Delay | 1 - 300 seconds | Same | |||
| Variable Jog Speeds | 0.5ml/sec, 1.5ml/sec, 8.0ml/sec | Same | |||
| Body weight Setting | Yes | Same | |||
| Body weight | 10-200kg 1kg increment | ||||
| 10-440lb 1lb increment | Same | ||||
| Contrast media | 300, 320, 350, 370, 400 | ||||
| or 3 preset parameter | Same | ||||
| Iodine volume | 10-1000 mg/kg | ||||
| 1mg/kg increment | Same | ||||
| Time | 0:01-5:00 or 3 preset parameter | Same | |||
| Volume Ratio | 5.95-95.5% 1% increment | Same | |||
| Injection Results History | 100 | 40 | |||
| Timing Bolus Duration | |||||
| Mode | Yes | No | |||
| Safety Stop Mechanism | Multi layered software stops with backup | ||||
| monitoring. | Same | ||||
| Syringe System | A-head: 200mL or 100mL syringe | ||||
| B-head: 200mL or 100mL syringe | A-head: 200mL or 100mL syringe | ||||
| B-head: 100ml syringe | |||||
| Programmed Volume | A or B-head: 1 to 200ml. or 1 to 100ml. | ||||
| (depending on syringe size) | Same | ||||
| Volume Remaining | |||||
| Readout | Graphic and numeric on LCD | Same | |||
| Flow Rate | 0.1mL/sec to 10mL/sec | Same | |||
| Programmable Pressure Limit | Settable from 10 to 300PSI | Same | |||
| Pause | Programmable – | ||||
| 1 sec to 300 seconds in 1sec increments | Same | ||||
| Quick Return | Fill rate 0.5, 1.5 and 8.0 mL/sec | Same function different name Auto-Return | |||
| Quick Purge | Yes | Yes | |||
| Remote Start Switch | Yes | Same | |||
| Pressure Graph | Yes | Same | |||
| Syringe Sensing | Yes | Same | |||
| Test Injection | Yes | Same | |||
| Syringe Heat Maintainer | Yes | Same | |||
| Power Saver Mode | Yes | No | |||
| Integrated Power Supply | Yes | No | |||
| Interlocking with CT scanner with NCOM | Yes | Yes | |||
| Injection Start | Yes | Yes | |||
| Injection Abort | Yes | Yes | |||
| Injection Hold | Yes | Yes | |||
| Powerhead Indicator lights | Yes | Yes | |||
| Power-on Self Test | Yes | Yes | |||
| Selectable Injection Patterns | Yes | Yes |
.
3
| Nemoto Kyorindo Co., Ltd. | Special 510k |
|---|---|
| 2-12-4 Aoki, Kawaguchi shi | Section 011 |
| Saitama, 332-0031 | Page 4 of 4 |
PERFORMANCE DATA:
The contrast delivery system Dual Shot Alpha 7 has been tested in conformance with the following recognized standards, and is substantially equivalent to the predicate device Dual Shot Alpha:
| EN 60601-1 (2006) | Medical Electrical Equipment, Part 1: General Requirements
for basic Safety and essential performance |
| ------------------- | ---------------------------------------------------------------------------------------------------------- |
|---|
- EN 60601-1-2 (2007) Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 60601-1-6 (2010) Medical electrical equipment Part 1-6: General requirements for safety and essential performance -Collateral standard. Usability
- EN 62304:2006 Medical Device Software - Software Life Cycle Processes
- EN 62366:2008 Medical Devices - Application of usability engineering to medical devices
- EN 1041:2008 Information supplied by the manufacturer with medical devices
- EN ISO13485:2012 Medical devices - Quality management systems -Requirements for regulatory purposes
- EN ISO14971:2012 Medical devices -- Application of risk management to medical devices
Biocompatibility testing has not been performed because the contrast delivery system Dual Shot Alpha 7 does not include a sterile syringe.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight.
Public Health Service
Food and Drug Administration ! 0903 New Hampshire Avenue Document Contro! Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Nemoto Kyorindo Co., Ltd. Ken Wakabayashi Vice Director 2-27-20 Hongo Bunkyo-ku Tokyo 113-0033 Japan
Re: K133189
Trade/Device Name: Dual Shot Alpha7 Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector with Syringe Regulatory Class: Class II Product Code: DXT Dated: April 4, 2014 Received: June 2, 2014
Dear Ken Wakabayashi,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
5
Page 2 - Ken Wakabayashi
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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 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.
M.A. Hilleman
for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section 009, Page 1 of 1
Indications for Use
510(k) Number (if known): 长133189
Device Name: DUAL SHOT alpha7
Indications for Use:
The DUAL SHOT alpha7 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).
Prescription Use O (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)
M.A. Hillemann