(344 days)
Not Found
No
The description focuses on the mechanical and user-programmed aspects of the injection system. There is no mention of AI, ML, or any learning or adaptive capabilities. The "Body Weight Protocol Programming Method" is explicitly stated to be a calculation based on operator input, not a predictive algorithm.
No.
The device is an injection system used for administering contrast media during MRI, which aids in diagnosis rather than directly treating a condition.
No
The device is a contrast delivery system for administering MRI contrast media and saline. It does not analyze or interpret medical data for diagnosis; its function is purely interventional (administering substances).
No
The device description clearly outlines hardware components such as the Console, Powerhead, and Main Control Unit, which are integral to the device's function of delivering contrast media.
Based on the provided information, the Sonic Shot GX contrast delivery system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI)." This describes a device used in vivo (within the living body) for delivering substances, not for testing samples in vitro (outside the living body).
- Device Description: The description details a system for injecting fluids into a patient, involving components like a console, powerhead, and syringes. This aligns with an in vivo delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Sonic Shot GX's function is to facilitate imaging by delivering contrast agents, which is a different purpose.
N/A
Intended Use / Indications for Use
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).
Product codes
IZQ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Intravascular, Venous injections
Indicated Patient Age Range
Not Found (Stated "Humans")
Intended User / Care Setting
Not Found (Implied clinician/operator in MR suite/scanning room, control room)
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)
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: 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: In all non-pressure limited injections the flow rate measured within the allowable ranges of the specification.
PRESSURE: During testing, the actual pressure was measured and compared to the displayed values and product specifications. All pressure readings were within the allowable specifications.
BODY WEIGHT PROTOCOL PROGRAMMING METHOD: 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: Over the range of various Drip Mode parameters, the Drip Mode performance was within the allowable specification ranges.
MANUAL CONTROL SPEEDS: During testing, both speeds (1ml/sec and 5ml/sec) were confirmed on the A and B sides to be within the allowable specification range.
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.
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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:
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).
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
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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 Contrast
Injections | 2 phases per protocol | 2 phases per protocol | 5 phases per protocol |
| Protocol Storage | 20 protocols | 20 protocols | Stores 20 injection
results |
| Injection History | Stores 20 injection
results | Stores 5 injection results | Stores 20 injection
results |
| 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 1ml
increments(60ml
syringe)
1-27 in 1ml increments
(25ml syringe) | 1-63ml in 1ml
increments | 1-61 in 1ml
increments(60ml
syringe)
1-27 in 1ml increments
(25ml syringe) |
| Flow Rate - A side | 25ml syringe:
0.1 - 8.0ml/sec in
0.1ml/sec increments
60ml syringe:
0.1 - 10.0 ml/sec
increments in 0.1 ml/sec
increments | 0.1 - 10.0 ml/sec
increments in 0.1 ml/sec
increments | 25ml syringe:
0.1 - 8.0ml/sec in
0.1ml/sec increments
60ml syringe:
0.1 - 10.0 ml/sec
increments in 0.1
ml/sec increments |
| Flow Rate - B side | 25 and 60ml syringe:
0.1 – 7.0 ml/sec
increments in 0.1 ml/sec
increments | 0.1 - 10.0ml/sec in
0.1ml/sec increments | 25 and 60ml syringe:
0.1 - 7.0 ml/sec
increments in 0.1
ml/sec increments |
| Pressure Limit | 25ml syringe: 200psi
60ml syringe: 150psi | 300psi | 25ml syringe: 200psi
60ml syringe: 150psi |
| Remote Start Switch | Yes | Yes | Yes |
| Mode for keeping a vein
open | Yes | Yes | Yes |
| Safety Stop Mechanism | Electrical stop when
injection parameters are
out of specification | Electrical stop when
injection parameters are
out of specification | Electrical stop when
injection parameters are
out of specification |
| User Interface Features
- Fill / Expel Control | Push button on head | Push button on head | Push button on head |
| - Air Detection | Operator visual
inspection | Operator visual
inspection | Operator visual
inspection |
| - Programming Injection | Touchscreen | Touchscreen | Touchscreen |
| - Status Display | Powerhead lights | Powerhead lights | Powerhead lights |
| Materials | Plastics and non-ferrous
metals | Plastics and non-ferrous
metals | Plastics and non-ferrous
metals |
| Anatomical Sites | Venous injections | Venous injections | Venous injections |
| Intended Use Statement | The injection of MR
contrast agents and
flushing solutions for the
purpose of enhancing
diagnostic imaging of
humans. | The injection of MR
contrast agents and
flushing solutions for the
purpose of enhancing
diagnostic imaging of
humans. | The contrast delivery
system Sonic Shot GX is
an intravascular
injection system
intended for the
administration of MRI |
| | | | normal saline solutions
used in conjunction with
magnetic resonance
imaging (MRI). |
| Target Population | Humans | Humans | Humans |
| Sterility | Consumables are
provided sterile | Consumables are
provided sterile | Consumables are
provided sterile |
| Body Weight Protocol
programming 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.
5
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
6
Page 2
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
7
Indications for Use
510(k) Number (if known): K091734
Device Name: Sonic Shot GX
Indications for Use:
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).
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