(93 days)
No
The document describes a contrast media injector with programmable parameters (volume, flow rate, pressure) and different injection protocols. There is no mention of AI, ML, or any algorithms that learn or adapt based on data. The testing focuses on verifying the accuracy of programmed parameters and safety mechanisms.
No
Explanation: The device is intended for injecting contrast media and flushing solution to aid in diagnostic imaging procedures (Angiographic and CT procedures), not directly for treating a disease or condition.
No
The device is an injector used to deliver contrast media for Angiographic and CT procedures. It aids in imaging by making vascular structures visible but does not in itself diagnose.
No
The device description clearly outlines hardware components such as a Console, Powerhead, Main Control Unit, and a ram that drives a lead screw to expel fluid from a syringe. While software controls the injection parameters, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures." This describes a device used in vivo (within a living organism) for medical imaging procedures.
- Device Description: The description details a mechanical system (Console, Powerhead, Main Control Unit, ram, syringe) designed to physically inject fluids into a patient.
- Anatomical Site: The specified anatomical site is "Arterial and Venous injections," which are within the patient's body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The description of the PRESS DUO elite and PRESS DUO elite AG does not involve the analysis of biological samples.
The device is a medical device used for administering substances directly into the patient's circulatory system for imaging purposes, which falls under the category of in vivo medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The main components of the PRESS DUO elite and PRESS DUO elite AG are the Console, Powerhead and Main Control Unit. The basic confiqurations of the PRESS DUO elite and PRESS DUO elite AG are a pedestal, ceiling mount or table mount configuration. With any configuration, the three main components are most often contained in the angiographic suite and normally near the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the graphical user interface with touchscreen input. The system is designed to deliver a variety of injection protocols. It can deliver single or multiple phase injections. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (like that used with laptop computers) and communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection by driving the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe. The only difference between the PRESS DUO elite and PRESS DUO elite AG is the availability of the CT Mode. The PRESS DUO elite provides both an Angiographic Mode and CT Mode of operation whereas the PRESS DUO elite AG has the CT Mode of operation turned off in the software and cannot be turned on by the user. All other software, hardware and mechanical aspects of the PRESS DUO elite and PRESS DUO elite AG are identical. 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 the contrast or common flushing solution 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 is communicated to the user Console to provide immediate feedback of injection operation. As highlighted in the Description section of this document there are 3 configurations for the PRESS DUO elite and PRESS DUO elite AG. These configurations refer to where the Powerhead component would be located 1) pedestal stand, 2) ceiling suspension system or 3) table rail mounted.
CONSOLE: The Console is the main user interface for the PRESS DUO elite and PRESS DUO elite AG. It provides a color graphical user interface with an overlying touchscreen for easy injection monitoring and injection setup. At the completion the injection results 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 normally in the angiographic suite and is typically located near the patient.
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 angiographic suite and communicates with the Console via a communications link.
SYRINGES AND ACCESSORIES: The PRESS DUO elite and PRESS DUO elite AG injection system have only one compatible syringe which is a 150ml single use disposable syringe as defined by 510(k) K090487, manufactured by Coeur, Inc. Other consumable accessories such as tubing, valves, stop cocks, are required to have luer connections compliant to ISO594-2 and shall have a pressure rating consistent with the pressure limit set-point on the PRESS DUO elite or PRESS DUO elite AG or a maximum of 1200PSI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Angiographic and Computed Tomography (CT)
Anatomical Site
Arterial and Venous injections
Indicated Patient Age Range
Humans
Intended User / Care Setting
Not Found
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
The sample size used for the testing was a single unit. The justification for testing only a single unit is based upon Nemoto Kyorindo Co., Ltd.'s long history of the PRESS DUO in the Japanese market for approximately 5 years. Performance testing was completed to verify the PRESS DUO elite and PRESS DUO elite AG contrast delivery systems are 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 substantial equivalence claims. Injection performance was tested to verify accuracy of delivered flow rate, volume, pressure and manual control speeds. The EMC, Electrical, Mechanical and Thermal Safety testing was performed using a prototype device, with no electrical, safety or structural mechanical differences between the tested device and final device. A footswitch was included in testing as an optional component for customers outside the USA, but it will not be provided to USA customers. All performance specifications when operating in the Angio Mode are identical between the PRESS DUO elite and PRESS DUO elite AG, and the PRESS DUO elite model can disable CT Mode to function as the PRESS DUO elite AG model, so separate testing was not necessary for the PRESS DUO elite AG. The only compatible syringe, a 150ml single use disposable syringe (K090487, Coeur, Inc.), was used for all testing. The 150ml connection point complies with ISO594-2 and is compatible with any tubing compliant to ISO594-2 and 1200PSI requirement. The extension tubing H-70 used in this testing is compatible with the required specifications. Needles (21G and 23G) were used to force pressure-limited injections to verify hardware and software mechanisms preventing over-pressure.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was completed to verify the PRESS DUO elite and PRESS DUO elite AG contrast delivery systems are 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 the substantial equivalence claims. Injection performance was tested to verify accuracy of delivered flow rate, volume, pressure and manual control speeds.
The EMC, Electrical, Mechanical and Thermal Safety testing was performed using a prototype device however there were no electrical, safety or structural mechanical differences between the tested device and final device.
The sample size used for the testing was a single unit.
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 and compared to the volume programmed. Over the range of volumes programmed, the PRESS DUO elite and PRESS DUO elite AG contrast delivery 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 PRESS DUO elite and PRESS DUO elite AG monitors the pressure to determine if the injection should be pressure limit is set for the syringe 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.
MANUAL CONTROL SPEEDS: The PRESS DUO elite and PRESS DUO elite AG have two speeds for manually moving the rams. By depressing the forward or reverse keys on the Powerhead, the rams can be moved at varying speeds. By pressing the forward or reverse key in combination with the accelerator key, the rams can be moved at maximum speed. During testing, speeds were confirmed to be within the allowable specification range.
USABILITY AND HUMAN FACTORS: The PRESS DUO elite and PRESS DUO elite AG were reviewed for usability and human factors and as a result of our use-related risk analysis, reference Section 16 document CB00-13-001F Section 8.8 useanalysis items 1 though 48 of the submission documents, the PRESS DUO elite and PRESS DUO elite AG do not contain critical task and all use-related risk are mitigated to be ALARP through design and product labeling as indicated in the CB00-13-001F document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963071, K133189, K092896, K132928
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
February 7, 2018
Nemoto Kyorindo Co., Ltd. Jim Knipfer General Manager, Overseas Department Profit Building 5F 2-27-3 Hongo, Bunkyo-ku Tokyo, Japan 113-0033
Re: K173450
Trade/Device Name: PRESS DUO elite, PRESS DUO elite AG Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: October 31, 2017 Received: November 6, 2017
Dear Jim 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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173450
Device Name PRESS DUO elite, PRESS DUO elite AG
Indications for Use (Describe)
The PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
NEMOTO KYORINDO CO., LTD
2-27-20 Hongo Bunkvo-ku. Tokyo 113-0033 Japan TELEPHONE +81- 3-5842-8571 FACSIMILE +81- 3-5805-0551
K173450
PRESS DUO elite and PRESS DUO elite AG Contrast Delivery System 510(k) Summary
| Contact Name: | Jim Knipfer |
|---|---|
| General Manager, Overseas Department | |
| Nemoto Kyorindo Co., Ltd. | |
| Profit Building 5F | |
| 2-27-3 Hongo, Bunkyo-ku | |
| Tokyo, Japan 113-0033 | |
| Phone: | +81-3-5842-8571 |
| FAX: | +81-3-5805-0551 |
| Date Prepared: | November 2, 2017 |
| Proprietary Name(s): | PRESS DUO elite, PRESS DUO elite AG |
| Common Name: | CT/Angiography Contrast Media Delivery System |
| Classification Name: | Injector and Syringe, Angiographic |
| Predicate Device(s): | Angiomat Illumena Injector, K963071 (Primary predicate) |
| Dual Shot alpha 7, K133189 (Secondary predicate) | |
| Rempress, K092896 (Secondary predicate) | |
| Medrad Mark 7 Arterion Injection System, K132928 (Secondary predicate) |
Indications for Use / Intended Use:
The PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Anqiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.
Description:
The main components of the PRESS DUO elite and PRESS DUO elite AG are the Console, Powerhead and Main Control Unit. The basic confiqurations of the PRESS DUO elite and PRESS DUO elite AG are a pedestal, ceiling mount or table mount configuration. With any configuration, the three main components are most often contained in the angiographic suite and normally near the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the graphical user interface
4
NEMOTO KYORINDO CO., LT
2-27-20 Hongo Bunkvo-ku. Tokyo 113-0033 Japan TELEPHONE +81- 3-5842-8571 +81- 3-5805-0551 FACSIMILE
with touchscreen input. The system is designed to deliver a variety of injection protocols. It can deliver single or multiple phase injections. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (like that used with laptop computers) and communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection by driving the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe. The only difference between the PRESS DUO elite and PRESS DUO elite AG is the availability of the CT Mode. The PRESS DUO elite provides both an Angiographic Mode and CT Mode of operation whereas the PRESS DUO elite AG has the CT Mode of operation turned off in the software and cannot be turned on by the user. All other software, hardware and mechanical aspects of the PRESS DUO elite and PRESS DUO elite AG are identical. 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 the contrast or common flushing solution 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 is communicated to the user Console to provide immediate feedback of injection operation. As highlighted in the Description section of this document there are 3 configurations for the PRESS DUO elite and PRESS DUO elite AG. These configurations refer to where the Powerhead component would be located 1) pedestal stand, 2) ceiling suspension system or 3) table rail mounted.
CONSOLE: The Console is the main user interface for the PRESS DUO elite and PRESS DUO elite AG. It provides a color graphical user interface with an overlying touchscreen for easy injection monitoring and injection setup. At the completion the injection results 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 normally in the angiographic suite and is typically located near the patient.
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 angiographic suite and communicates with the Console via a communications link.
SYRINGES AND ACCESSORIES: The PRESS DUO elite and PRESS DUO elite AG injection system have only
5
NEMOTO KYORINDO CO., LTD
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japar TELEPHONE +81- 3-5842-8571 FACSIMILE +81- 3-5805-0551
one compatible syringe which is a 150ml single use disposable syringe as defined by 510(k) K090487, manufactured by Coeur, Inc. Other consumable accessories such as tubing, valves, stop cocks, are required to have luer connections compliant to ISO594-2 and shall have a pressure rating consistent with the pressure limit set-point on the PRESS DUO elite or PRESS DUO elite AG or a maximum of 1200PSI.
SUBSTANTIAL EQUIVALENCE
A comparison chart shown in Table 1 compares the technological characteristics of the PRESS DUO elite and PRES DUO elite AG contrast delivery systems to the predicate devices the Liebel-Flarseim's Angiomat Illumena, Nemoto's Dual Shot alpha 7, Nemoto's Rempress and Medrad Mark 7 Arterion. The PRESS DUO elite and PRESS DUO elite AG is substantially equivalent to the predicate devices.
6
NEMOTO KYORINDO CO., LTD.
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
| Characteristic / Feature | Angiomat Illumena
(Primary Predicate)
K963071 | Dual Shot alpha 7
(Secondary Predicate)
K133189 | REMPRESS
(Secondary Predicate)
K092896 | Medrad Mark 7 Arterion
(Secondary Predicate)
K132928 | PRESS DUO elite
PRESS DUO elite AG
(K173450) | Device Comparison
Result |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Multi-phasic Injections | 4 phases per protocol | 5 phases per protocol | 1 phase per protocol | 4 phases per protocol | 2 phase per protocol | Same |
| Single or Dual Syringe | Single | Dual | Single | Single | Dual | Same |
| Angio and CT Modes | Angio, CT | CT | Angio | Angio | Angio, CT | Same |
| Infusion Mode | Yes | No | Yes | No | Yes | Same |
| Protocol Storage | 45 protocols (Angio Mode)
45 protocol (CT Mode) | 400 protocols | 20 protocols | 40 protocols | 240 protocols | Inside Specification |
| X-ray/Scan Delay | 0 - 300 secs. | 0 – 300 secs | 0 - 99 secs | 0 - 99.9 secs | 0 - 99.9 secs | Inside Specification |
| Inject Delay | 0 - 300 secs. | No | 0 - 99 secs | 0 - 99.9 secs | 0 - 99.9 secs | Inside Specification |
| Inter-phase Delay | 0 - 300 secs. | 0 – 300 secs | None | Not indicated | None | Same |
| Syringe System | 150ml or 125ml | 100ml or 200ml | 150ml | 150ml | 150ml | Same |
| Volume Remaining Display | LED display on Powerhead | Optional Powerhead display | LED display on Powerhead | Color LCD | LED display on Powerhead | Same |
| Filling Rate | 3 to 25ml/sec (manual) | 0.5ml/sec, 1.5ml/sec and
8.0ml/sec | 0.5 – 2.5ml/sec | 1 - 10ml/sec | 0.5 – 2.5ml/sec | Same |
| Rise Time | 0 to 10 seconds | Off = 0 secs, On = 2 secs | 0 - 9.9 seconds | 0 - 9.9 secs | 0 - 9.9 seconds | Same |
| Arming Modes | Single or Multi | Single | Single or Multi | Single or Multi | Single or Multi | Same |
| Variable Jog Speeds | Yes | Yes | Yes | Yes | Yes | Same |
| Body Weight Protocol | No | Yes | No | No | No | Same |
| Quick Return | No | Yes (see Filling Rate) | No | Not Indicated | Yes (see Filling Rate) | Same |
| Quick Purge | No | Yes | No | Not Indicated | Yes | Same |
| Remote Start | Yes | Yes | Yes | Yes | Yes | Same |
| Pressure Graph | Not indicated | Yes | Yes | No | Yes | Same |
| Syringe Heater | Yes | Yes | Yes | Yes | Yes | Same |
| Interlocking with Angio | Yes | No | Yes | Yes | Yes | Same |
| Interlocking with CT | Not indicated | Yes | No | No | No | Same |
| Injection Abort | Yes | Yes | Yes | Yes | Yes | Same |
| Powerhead Indicator Lights | Yes | Yes | Yes | Yes | Yes | Same |
| Power-On Self-Test | Yes | Yes | Yes | Yes | Yes | Same |
| Selectable Inject Patterns | Yes | Yes | Yes | Yes | Yes | Same |
| Variable Flow Rate | No | No | Yes - optional | Yes - optional | No | Same |
| Flow Rate | 0.1 to 40ml/sec for
125/150ml syringe (Angio
Mode)
0.1 to 10.0ml/sec in (CT
Mode)
0.1 to 99ml/min for infusion
purposes | 0.1 to 10ml/sec in 0.1ml/sec
increments | 0.1 to 25ml/sec with 150ml
syringe
0.1 to 99ml/min for infusion
purposes | 0.1 to 45ml/sec in
0.1ml/sec increments
0.1 to 59.9ml/min in
0.1ml/min (not specified as
infusion mode but operates
at infusion rates) | 0.1 to 30ml/sec in
0.1ml/sec increments
(Angio Mode)
0.2 to 10.0ml/sec in
0.1ml/sec increments (CT
mode) | Inside Specification |
| Pressure Limit | 75 - 1200 PSI (Angio Mode)
75 - 300 (CT Mode) | 25 to 300 PSI | 50 - 1200 PSI | 100 – 1200 PSI | 50-1200 PSI (Angio Mode)
50-300 PSI (CT Mode) | Same |
| Remote Start Switch | Yes | Yes | Yes | Yes | Yes | Same |
| Test Shot | Yes (Re-Arming) | No | Yes (Trace Shot) | Yes (Re-arming) | Yes (Re-Arming) | Same |
| Safety Stop Mechanism | Electrical stop when
injection parameters are
out of specification | Electrical stop when
injection parameters are out
of specification | Electrical stop and
mechanical backup stopper
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 | Same |
| User Interface Features | | | | | | |
| - Fill / Expel Control | Yes | Yes | Yes | Yes | Yes | Same |
| - Air Detection | Operator visual inspection | Operator visual inspection | Operator visual inspection | Operator visual inspection | Operator visual inspection | Same |
| FACSIMILE
+81- 3-5805-0551 | | | | | | |
| Status Display | Powerhead lights | Powerhead lights | Powerhead lights | Powerhead lights | Powerhead lights | Same |
| Console Display | Color LCD with touchscreen | Color LCD with touchscreen | Color LCD with touchscreen | Color LCD with touchscreen | Color LCD with touchscreen | Same |
| Materials | Plastics and metals | Plastic and metals | Plastics and metals | Plastic and metals | Plastic and metals | Same |
| Anatomical Sites | Arterial and Venous injections | Arterial and venous injections | Arterial and Venous injections | Arterial and Venous injections | Arterial and Venous injections | Same |
| Intended Use Statement | The Angiomat Illumena is
designed to inject
radiopaque contrast
medium into the vascular
system for Angiography
and CT procedures as
prescribed by qualified
health care professionals. | 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). | The contrast delivery
system REMPRESS is an
intravascular injection
system intended for the
administration of contrast
media or flushing solutions
used in conjunction with
angiographic imaging
procedures. | The MEDRAD Mark 7
Arterion Injection system is
intended to be used
specifically for the purposes
of injecting contrast
medium and common
flushing solutions into
humans for angiographic
studies. | The PRESS DUO elite is
intended to be used for
injecting contrast media
and common flushing
solution into the vascular
system in Angiographic and
Computed Tomography
(CT) procedures whereas
the PRESS DUO elite AG is
intended to be used for
injecting contrast media
and common flushing
solution into the vascular
system for Angiographic
procedures only. | Same |
| Target Population | Humans | Humans | Humans | Humans | Humans | Same |
7
NEMOTO KYORINDO CO., LTD.
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
TELEPHONE +81- 3-5842-8571
8
EMOTO KYORINDO CO., LT
2-27-20 Hongo Bunkvo-ku. Tokvo 113-0033 Japan TELEPHONE +81- 3-5842-8571 +81- 3-5805-0551 FACSIMILE
SUMMARY OF PERFORMANCE TESTING
Performance testing was completed to verify the PRESS DUO elite and PRESS DUO elite AG contrast delivery systems are 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 the substantial equivalence claims. Injection performance was tested to verify accuracy of delivered flow rate, volume, pressure and manual control speeds.
The EMC, Electrical, Mechanical and Thermal Safety testing was performed using a prototype device however there were no electrical, safety or structural mechanical differences between the tested device and final device. A ferrite bead shown in the test reports for the prototype device is also included in the final device. One variation between the tested device and the final device is a Footswitch. The Footswitch was included in the testing as this optional component is provided to our customers outside of the USA however it would not be provided to USA customers since the option is not required.
Testing was not specifically performed with the PRESS DUO elite AG model however the functionality of the PRESS DUO elite AG can be tested using the PRESS DUO elite model since it can perform both angiographic functions and the CT functions which are not included in the PRESS DUO elite AG. The utilization of the PRESS DUO elite further permits this disabling of the CT Mode thereby making it a PRESS DUO elite AG model. All performance specifications when operating in the Angio Mode are identical between the PRESS DUO elite and PRESS DUO elite AG, therefore separate testing was not necessary to confirm the PRESS DUO elite AG operation.
The sample size used for the testing was a single unit of the justification for testing only a single unit is based upon our long history of the PRESS DUO in the Japanese market. The PRESS DUO has been on the Japanese market for approximately 5 years therefore the performance of the device is well understood and substantiated by the existing market.
With respect to consumables used during the testing, the only compatible syringe is the 150ml disposable syringe identified in K090487, which is reflected in the User Manual. Therefore, the 150ml syringe was used for all testing. The 150ml connection point is compliant to ISO594-2 therefore compatible with any tubing compliant to ISO594-2 and 1200PSI requirement. The ISO594-2 and 1200PSI requirements are also reflected in the updated User Manual. The extension tubing H-70 used in this testing is compatible with the required specifications. All needles and catheters on the market today that comply with the ISO594-2 specification can be used with the 150ml syringe in K090487 which is compatible with the Protection Cover
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EMOTO KYORINDO CO., LT
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that is used with the PRESS DUO elite and PRESS DUO elite AG.
To develop injection pressure various needles are used during the performance testing to ensure the injector can be forced to perform a pressure limited injection. A pressure limited injection is required to verify the necessary hardware and software mechanisms are in place and functioning correctly to prevent an over pressure limit situation from presenting itself. Various need to enable the pressure limit condition to occur at different Flow Rates. The 21G and 23G needle sizes are sufficient to force the injector device into pressure limit conditions at various flow rate values. Since the pressure is limited by the injector a smaller orifice size would not cause the pressure to limit to change. For example, the execution of an injection using a 23G needle which is pressure limiting at 500PSI would still pressure limit at 500PSI using a 24G (smaller) needle. The pressure limit is set by the injector device and not by the needle, tubing etc.
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 and compared to the volume programmed. Over the range of volumes programmed, the PRESS DUO elite and PRESS DUO elite AG contrast delivery 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 PRESS DUO elite and PRESS DUO elite AG monitors the pressure to determine if the injection should be pressure limit is set for the syringe 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.
MANUAL CONTROL SPEEDS
The PRESS DUO elite and PRESS DUO elite AG have two speeds for manually moving the rams. By
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depressing the forward or reverse keys on the Powerhead, the rams can be moved at varying speeds. By pressing the forward or reverse key in combination with the accelerator key, the rams can be moved at maximum speed. During testing, speeds were confirmed to be within the allowable specification range.
USABILITY AND HUMAN FACTORS
The PRESS DUO elite and PRESS DUO elite AG were reviewed for usability and human factors and as a result of our use-related risk analysis, reference Section 16 document CB00-13-001F Section 8.8 useanalysis items 1 though 48 of the submission documents, the PRESS DUO elite and PRESS DUO elite AG do not contain critical task and all use-related risk are mitigated to be ALARP through design and product labeling as indicated in the CB00-13-001F document.
CONCLUSION
The PRESS DUO elite and PRESS DUO elite AG contrast demonstrated their ability to perform within its specified parameters and operate as intended by the users of the devices. As a result, its performance is deemed acceptable and substantially equivalent to the predicate devices.