The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).

Device Description

The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and saline used in conjunction with MRI.

The main components of the Sonic Shot GX are the Console, Powerhead and Main Control Unit. The Console resides in the control room or the MR suite, while the Main Unit and Powerhead reside in the scanning room alongside the MR scanning device and the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that used with laptop computers) and communicates with Main Control Unit via a fiber-optic interface. The communication link is used to communicate the user set injection parameters to the Main Control and Powerhead located in the MR suite.

After the injection protocol has been set, the Powerhead performs the injection by driving one or two lead screw rams. The rams push the syringe which expels fluid from the barrel of the syringe.

AI/ML Overview

The provided document describes a contrast delivery system (Sonic Shot GX) and primarily focuses on its substantial equivalence to predicate devices, rather than a detailed study report for meeting acceptance criteria of an AI/ML powered medical device. Therefore, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth for AI models) is not applicable or not present in the provided text, as the device is a hardware injector, not an AI system.

However, I can extract information related to the performance testing done to verify the system meets its specifications.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The "Summary of Performance Testing" section describes that the device must be capable of achieving "specification parameters for the system as outlined in the substantial equivalence chart." The "Performed Testing" section describes how the device meets those specifications.

Characteristic / Feature (Acceptance Criteria Implicit in Design Parameters)	Reported Device Performance
Volume Delivery	Successfully delivered volumes within allowable specifications across the programmed range.
Flow Rate Delivery	Measured within allowable ranges of specification for all non-pressure limited injections. (Note: Pressure limit injections automatically reduce flow rate to maintain constant pressure).
Pressure Monitoring	All pressure readings were within allowable specifications (compared to displayed values and product specifications).
Body Weight Protocol Programming Method	Calculates volume based on patient weight and active ingredient units as entered by the operator. Performance implicitly met, as it's a computational function.
Drip Mode Performance	Performance was within allowable specification ranges over various Drip Mode parameters.
Manual Control Speeds (1ml/sec and 5ml/sec)	Both speeds were confirmed on A and B sides to be within the allowable specification range.

Note: The document refers to "allowable specifications" and "allowable ranges," implying specific numerical thresholds, but these thresholds are not explicitly stated in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document states "During testing" or "Over the range of volumes programmed" but does not provide specific numbers of tests or injections performed.
Data Provenance: Not specified, but given the manufacturer is Nemoto Kyorindo Co., Ltd. in Japan, it is highly likely the testing was conducted in Japan. The testing described is prospective, as it involves actively performing injections and measuring parameters.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is a contrast delivery system (hardware), not an AI/ML-driven diagnostic or interpretative device that requires expert-established ground truth for its performance. The "ground truth" here is the physical measurement of fluid dynamics and pressure, compared against engineered specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The performance evaluation relies on objective physical measurements against engineering specifications, not subjective expert judgment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The Sonic Shot GX is a hardware device for injecting contrast media, not a system that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The Sonic Shot GX is a mechanical injector. Its performance is measured as a standalone system (it delivers fluid autonomously once programmed), but it does not have an "algorithm-only" performance in the context of AI/ML or image interpretation. Its performance is its standalone mechanical and electronic function.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the Sonic Shot GX involves objective physical measurements of:

Delivered volume
Measured flow rate
Actual pressure
Drip mode increments and intervals
Manual control speeds

These measurements are compared against the engineering specifications defined for the device.

8. The Sample Size for the Training Set

This information is not applicable. The Sonic Shot GX is not an AI/ML device that requires a training set. Its functionality is based on pre-programmed logic and mechanical engineering, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

Summary

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K091734
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NEMOTO KYOR.

2-27-20 Honao Bunkvo-ku. Tokyo 113-00 EPHONE +81- 3-5842 81- 3-5842-858

MAY 2 1 2010

Sonic Shot GX Contrast Delivery System 510(k) Summary

Contact Name:

Jim Knipfer

Executive Director, Technical Center Nemoto Kyorindo Co., Ltd. 2-12-4 Aoki, Kawaguchi Saitama, Japan 332-0031 Phone: +81-48-250-3255 FAX: +81-48-250-3256

Proprietary Name: Common Name: Classification Name: Predicate Device(s):

Sonic Shot GX Injector System Injector and Syringe, Angiographic Optistar MR Injector System (K984088) Medrad Spectris Solaris MR Injector System (K042784)

Intended Use:

Description:

The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and saline used in conjunction with MRI.

After the injection protocol has been set, the Powerhead performs the injection by driving one or two lead

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ongo Bunkyo-ku. Tokyo FPHONE +81- 3-5842 +81-3-5847

screw rams. The rams push the syringe which expels fluid from the barrel of the syringe. The following paragraphs provide more details for each of these main components.

POWERHEAD: The Powerhead provides a means for accepting and identifying a given syringe and then applying a force to the plunger of the syringe via its screw driven ram which will eject MR contrast or normal saline from the barrel of the syringe. The Powerhead is in constant communications with the Main Control Unit for determining injection protocol and to monitor all Powerhead functions and injection sequences. The injection information is communicated to the user Console to provide immediate feedback of injection operation. The Powerhead resides in the MR scanning room.

CONSOLE: The Console is the main user interface for the Sonic Shot GX. It provides a color graphical user interface with an overlying touchscreen for easy injection setup. At the completion of an injection the injection result are clearly displayed to the user. The Console provides a connection for a remote Handswitch that can be used to start or stop an injection. The Console resides outside the MR scanning room and is typically located near the control console for the MR scanning equipment.

MAIN CONTROL UNIT: The Main Control Unit is the interface between the Console and the Powerhead. The Main Control Unit receives the user input data from the Console and converts to the necessary control information then relays to the Powerhead. The Main Control unit also provides the power necessary to operate the Powerhead. The Main Control Unit is located inside the MR scanning room and communicates with the Console via a fiber-optic cable.

The system is designed to deliver a variety of injection protocols. It can deliver single or multiple phase injections consisting of contrast, saline or both simultaneously. To enable the user to perform a variety of iniection protocols the Powerhead provides for two syringes to be used and the Console provides a flexible user interface to enable simple and easy protocols can then be stored onto a removable memory card. The injection system is also provided with a variety of consumables products for connecting the syringes to the patient.

SUBSTANTIAL EQUIVALENCE

A comparison chart shown in Table 1 compares the technological characteristics of the Sonic Shot GX contrast delivery system to the predicate devices the Liebel-Flarseim's Optistar MR and Medrad's Sprectris Solaris MR Injector System. The Sonic Shot GX is substantially equivalent to the predicate devices. The Sonic Shot GX injector system safely and effectively injects MR contrast and normal saline solutions as desired by the user in an MR environment.

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్ Nemoto

NEMOTO KYORINDO CO., LTD.

2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
FACSIMILE - - FACSIMILE - - 81-3-5842-8589

2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
TELEPHONE +81-3-5842-8571

FACSIMILE +81-3-5842-8

Characteristic /Feature	Optistar MR(Predicate device)	Sprectris Solaris(Predicate Device)	Sonic Shot GX(New Device)
Multi-phasic ContrastInjections	2 phases per protocol	2 phases per protocol	5 phases per protocol
Protocol Storage	20 protocols	20 protocols	Stores 20 injectionresults
Injection History	Stores 20 injectionresults	Stores 5 injection results	Stores 20 injectionresults
Scan Delay	00:00 - 00:59 minutes	00:00 - 00:59 minutes
Syringe System - A side	60ml or 25ml	65ml	60ml or 25ml
Syringe System - B side	60ml or 25ml	65ml	60ml or 25ml
Volume	1-61 in 1mlincrements(60mlsyringe)1-27 in 1ml increments(25ml syringe)	1-63ml in 1mlincrements	1-61 in 1mlincrements(60mlsyringe)1-27 in 1ml increments(25ml syringe)
Flow Rate - A side	25ml syringe:0.1 - 8.0ml/sec in0.1ml/sec increments60ml syringe:0.1 - 10.0 ml/secincrements in 0.1 ml/secincrements	0.1 - 10.0 ml/secincrements in 0.1 ml/secincrements	25ml syringe:0.1 - 8.0ml/sec in0.1ml/sec increments60ml syringe:0.1 - 10.0 ml/secincrements in 0.1ml/sec increments
Flow Rate - B side	25 and 60ml syringe:0.1 – 7.0 ml/secincrements in 0.1 ml/secincrements	0.1 - 10.0ml/sec in0.1ml/sec increments	25 and 60ml syringe:0.1 - 7.0 ml/secincrements in 0.1ml/sec increments
Pressure Limit	25ml syringe: 200psi60ml syringe: 150psi	300psi	25ml syringe: 200psi60ml syringe: 150psi
Remote Start Switch	Yes	Yes	Yes
Mode for keeping a veinopen	Yes	Yes	Yes
Safety Stop Mechanism	Electrical stop wheninjection parameters areout of specification	Electrical stop wheninjection parameters areout of specification	Electrical stop wheninjection parameters areout of specification
User Interface Features- Fill / Expel Control	Push button on head	Push button on head	Push button on head
- Air Detection	Operator visualinspection	Operator visualinspection	Operator visualinspection
- Programming Injection	Touchscreen	Touchscreen	Touchscreen
- Status Display	Powerhead lights	Powerhead lights	Powerhead lights
Materials	Plastics and non-ferrousmetals	Plastics and non-ferrousmetals	Plastics and non-ferrousmetals
Anatomical Sites	Venous injections	Venous injections	Venous injections
Intended Use Statement	The injection of MRcontrast agents andflushing solutions for thepurpose of enhancingdiagnostic imaging ofhumans.	The injection of MRcontrast agents andflushing solutions for thepurpose of enhancingdiagnostic imaging ofhumans.	The contrast deliverysystem Sonic Shot GX isan intravascularinjection systemintended for theadministration of MRI
			normal saline solutionsused in conjunction withmagnetic resonanceimaging (MRI).
Target Population	Humans	Humans	Humans
Sterility	Consumables areprovided sterile	Consumables areprovided sterile	Consumables areprovided sterile
Body Weight Protocolprogramming method	No	No	Yes

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NEMOTO KYORINDO CO., LTD..
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan

TELEPHONE +81- 3-5842-8571
FACSIMILE +81- 3-5842-8589

SUMMARY OF PERFORMANCE TESTING

Performance testing was completed in order to verify the Sonic Shot GX contrast delivery system was capable of achieving the specification parameters for the system as outlined in the substantial equivalence chart. Verification of the system's ability to accurately achieve these validates the substantial equivalence claims. Injection performance was tested to accuracy of delivered flow rate, volume (including Body Weight Protocol Programming Method), pressure, Drip Mode and manual control speeds.

VOLUME

Fluid delivery of an injector is characterized by three primary parameters, flow rate, volume and pressure limit. The volume delivered is the most critical parameter in that is has the greatest effect on image quality. During testing, the volume delivered was accurately measured to the volume programmed. Over the range of volumes programmed, the Sonic Shot GX system successfully delivered the volumes within the allowable specifications.

FLOW RATE

The second most critical variable parameter in delivering fluid to a patient is the flow rate. During the test injections, the injection time and volume were recorded then the flow rate calculated. In the event of a pressure limit injection, the volume and time are known not to accurately represent the flow rate therefore the data was omitted from this specific calculation. In all non-pressure limited injections the flow rate measured within the allowable ranges of the specification. NOTE: Pressure limit injections automatically reduce the flow rate from the user set flow rate to maintain a constant pressure, as desired by the operator.

PRESSURE

During all injections, the injector monitors the pressure in order to determine if the injection should be pressure limited. An upper limit is set for each syringe type used in the injector in order to avoid failure of the syringe. During testing, the actual pressure was measured and compared to the displayed values and product specifications. All pressure readings were within the allowable specifications.

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Honon Bunkvo-ku To FIFFHONE +81- 3-5842 FACSIMILE +81-3-5847

BODY WEIGHT PROTOCOL PROGRAMMING METHOD

The volume of contrast required for an injection is based upon a patient's body weight. Normally, the amount of active ingredient (units: mmol/kg) are multiplied by the weight (kg) to give a volume (ml). The calculation is often performed manually or pre-calculated and a look-up sheet is provided to the clinician. The Sonic Shot GX provides a.mode wherein this calculation can be performed by the injector as convenience for the operator. The Body Weight Protocol Programming does not predict the volume required, it simply calculates the volume based upon the patient weight and active ingredient units entered by the operator.

DRIP MODE

Drip Mode is used to keep a catheter or vein open. The injector achieves this by administering small increments of fluid (normal saline) over short time intervals. The injector allows the programming of the volume increment, time interval and flow rate. The performance of Drip Mode was evaluated during testing. Over the range of various Drip Mode parameters, the Drip Mode performance was within the allowable specification ranges.

MANUAL CONTROL SPEEDS

The Sonic Shot GX as two speeds for manually moving the rams. By depressing the forward or reverse keys on the Powerhead, the rams can be moved at 1ml/sec. By pressing the forward or reverse key in combination with the accelerator key, the rams can be moved at 5ml/sec. During testing, both speeds were confirmed on the A and B sides to be within the allowable specification range.

CONCLUSION

The Sonic Shot GX contrast delivery system provided its ability to perform within its specified parameters. As a result, its performance is deemed acceptable and substantially equivalent to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Jim Knipfer Executive Dricetor of Technical Center Nemoto Kyorindo Co., Ltd. 2.12.4 Aok Kawaguchi-Shi, Saitama, 332-0031 JAPAN

MAY 2 1 2010

Re: K091734

Trade/Device Name: Sonic Shot GX Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II Product Code: IZQ Dated: February 15, 2010 Received: March 19, 2010

Dear Mr. Knipfer:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportaProblem/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/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K091734

Device Name: Sonic Shot GX

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

Page 1 of

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

signature

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K091734

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.