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).

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, Console, and optional Hand Switch.

AI/ML Overview

The medical device, "Contrast Delivery System - Dual Shot Alpha 7" by Nemoto Kyorindo Co., Ltd., is an angiographic injector intended for the administration of ionic and non-ionic contrast media and saline in conjunction with computed X-ray tomography (CT).

Here's an analysis of its acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Recognized Standards)	Reported Device Performance
Safety and Essential Performance
EN 60601-1 (2006): Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance	The device has been tested in conformance with this standard.
Electromagnetic Compatibility (EMC)
EN 60601-1-2 (2007): Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests	The device has been tested in conformance with this standard.
Usability
EN 60601-1-6 (2010): Medical electrical equipment Part 1-6: General requirements for safety and essential performance - Collateral standard. Usability	The device has been tested in conformance with this standard.
EN 62366:2008: Medical Devices - Application of usability engineering to medical devices	The device has been tested in conformance with this standard.
Software Life Cycle Processes
EN 62304:2006: Medical Device Software - Software Life Cycle Processes	The device has been tested in conformance with this standard.
Information Supplied by Manufacturer (Labeling)
EN 1041:2008: Information supplied by the manufacturer with medical devices	The device has been tested in conformance with this standard.
Quality Management Systems
EN ISO13485:2012: Medical devices - Quality management systems - Requirements for regulatory purposes	The device has been tested in conformance with this standard.
Risk Management
EN ISO14971:2012: Medical devices -- Application of risk management to medical devices	The device has been tested in conformance with this standard.
Biocompatibility	Not applicable, as the device does not include a sterile syringe and therefore does not have direct patient contact necessitating biocompatibility testing.

Study Proving Device Meets Acceptance Criteria:

The provided document describes the "Special 510(k) SUMMARY" for the Dual Shot Alpha 7, which establishes substantial equivalence to a predicate device (Dual Shot Alpha K062168 and K071691). The study proving the device meets acceptance criteria is a compliance study with recognized international and European standards for medical devices, rather than a clinical effectiveness study.

The document states: "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." This implies that a series of tests and evaluations were conducted to demonstrate the device's adherence to the specified standards listed in the table above.

Key Information Requirements and Their Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the summary. The "test set" here refers to the performance of the physical device against engineering and safety standards. Details on the specific number of devices tested, samples of injection cycles, or environmental testing conditions are not disclosed.
- The data provenance is not specified beyond the manufacturer being based in Saitama, Japan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This type of information is not applicable to this submission. The "ground truth" in this context is the adherence to engineering specifications and safety standards, which would be verified by internal testing personnel, qualified engineers, and potentially third-party testing labs, not medical experts establishing diagnostic ground truth from images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable to this type of device and submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple readers evaluate medical images against a consensus or pathological truth. This submission focuses on engineering and regulatory compliance.
If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a contrast delivery system (an angiographic injector), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a hardware system with embedded software, not a standalone algorithm for image analysis or diagnosis. Its performance is evaluated in terms of its mechanical, electrical, and software compliance, not "algorithm-only" performance as understood in AI/ML medical devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance directly relates to its adherence to the specified recognized standards (EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 62304, EN 62366, EN 1041, EN ISO13485, EN ISO14971). This "ground truth" is established through objective measurements, calibration, and engineering tests to verify parameters like flow rate accuracy, pressure limits, software functionality, electrical safety, usability engineering principles, and risk management processes. It is based on predefined technical specifications and regulatory requirements, not medical diagnostic outcomes.
The sample size for the training set:
- This information is not provided and is not applicable in the context of this device. The phrase "training set" is typically used for machine learning models. The software in this device would have undergone traditional software development lifecycle verification and validation, not machine learning model training.
How the ground truth for the training set was established:
- This information is not applicable as there is no "training set" in the machine learning sense for this device. The software development process would involve requirements definition, design specification, implementation, and rigorous testing against those specifications, which serve as the "ground truth" for software functionality.

Summary

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Nemoto Kyorindo Co., Ltd.
2-12-4 Aoki, Kawaguchi-shi
Saitama, 332-0031

JUN 3 0 2014 K133189

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:

DESCRIPTION OF DEVICE:

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;

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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,

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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 ShotAlpha 7 is an intravascular injectionsystem intended for the administration ofionic and non-ionic contrast media andsaline used in conjunction with computedX-ray tomography (CT).	Same
Single or Dual SyringeSystem	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 StorageCapability	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 increment10-440lb 1lb increment	Same
Contrast media	300, 320, 350, 370, 400or 3 preset parameter	Same
Iodine volume	10-1000 mg/kg1mg/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 DurationMode	Yes	No
Safety Stop Mechanism	Multi layered software stops with backupmonitoring.	Same
Syringe System	A-head: 200mL or 100mL syringeB-head: 200mL or 100mL syringe	A-head: 200mL or 100mL syringeB-head: 100ml syringe
Programmed Volume	A or B-head: 1 to 200ml. or 1 to 100ml.(depending on syringe size)	Same
Volume RemainingReadout		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

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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 Requirementsfor 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.

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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

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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

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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

Regulation Number and Section

§ 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.