(403 days)
Not Found
No
The summary describes a standard contrast delivery system with programmable parameters and mechanical injection. There is no mention of AI, ML, or any features that would suggest the use of such technologies for decision-making, image analysis, or adaptive control.
No
The device is described as an intravascular injection system for administering contrast media or saline during angiographic imaging procedures, not for treating a disease or condition.
No
The device is an intravascular injection system for administering contrast media or saline during angiographic imaging procedures, not for diagnosing conditions.
No
The device description clearly outlines hardware components like a Console, Powerhead, and Main Control Unit, and describes their physical interaction and function in delivering contrast media. This is not a software-only device.
Based on the provided information, the REMPRESS contrast delivery system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "intravascular injection system intended for the administration of contrast media or normal saline used in conjunction with angiographic imaging procedures." This describes a device used in vivo (within the body) for delivering substances, not a device used in vitro (outside the body) for examining specimens like blood, tissue, or urine.
- Device Description: The description details a system for injecting fluids into a patient, involving components like a console, powerhead, and syringe. This aligns with an in vivo delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the REMPRESS is a medical device used for administering substances during imaging procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The contrast delivery system REMPRESS is an intravascular injection system intended for the administration of contrast media or normal saline used in conjunction with angiographic imaging procedures.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The main components of the REMPRESS are the Console, Powerhead and Main Control Unit. The configurations of the REMPRESS are a pedestal or table mount configuration which are possible in the angiographic suite and normally in close proximity to 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 inputs. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that integrated into the predicate devices) and communicates with Main Control Unit communications interface via a single connection cable. After the injection protocol has been set, the Powerhead performs the injection via the contribution of the lead screw ram. The ram pushes the push-rod of 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 the 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.
CONSOLE: The Console is the main user interface for the REMPRESS. It provides a color graphical user interface with an overlying touchscreen for easy injection monitoring and injection setup. At the completion of an injection 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.
The system is designed to deliver a variety of injection protocols. The REMPRESS 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
Angiographic imaging
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
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 system as outlined in the substantial equivalence chart. For achieving the specification parameters for the system, the values were measured and verification of the system daily showed accuracy of delivered flow rate, volume, pressure and manual control speeds.
VOLUME: Fluid delivery of an injector is the most critical parameter in that it has the greatest effect on image quality. The volume delivered was accurately measured and compared to the volume programmed. During testing, the REMPRESS 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. In the event of injections, the injection time and volume were recorded then the flow rate calculated. The data was officed from this Specification. NOTE: Pressure limit injections only 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 avoid failure of the syringe. During an injection, the injector monitors the pressure in the syringe. An upper limit is set by the operator and the measured pressure values were within the allowable ranges.
MANUAL CONTROL SPEEDS: The REMPRESS has two speeds for manually moving the forward or reverse key in combination with the accelerator key. During testing, speeds were confirmed to be within the allowable specification range.
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.
Angiomat Illumena Injector, K963071, Angiomat 6000 Injector, K860204
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.
Not Found
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
NEMOTO KYORINDO CO., LTD.
20 Hongo Bunkvo-ku. Toky +81- 3-584 EDHONE +81- 3-5842-8589
K092896
OCT 29 2010
REMPRESS 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: | REMPRESS |
Common Name: Classification Name: Predicate Device(s):
Injector System Injector and Syringe, Angiographic Angiomat Illumena Injector, K963071 Angiomat 6000 Injector, K860204
Intended Use:
Intended USE.
The contrast delivery system REMPRESS is an intravascular injection system intended for the administration r fie contrast delivery of over in conjunction with angiographic imaging procedures.
Of contrast media or normal saline used in conjunction with angiographic imaging procedu
Description:
Description:
The main components of the REMPRESS are the Console, Powerhead and Main Control Unities parfiguration The main components of the REM RED are a pedestal or table mount configuration the partiguration the parayimity contigurations of the KENI NESS are a possible in the angiographic suite and normally in close proximity. three main components of the injection, such as volume, flow rate and pressure are programmed by to the patient. The parameters of the injection) and the Console is powered via 24 volts DC
the operator via the graphical user interface with touchscreen inputers) and the operatur via the gruption assi. Includes
which is derived from a remote AC to DC converter (similar to that integrine protocol has which is defived from a remote AC to DG connections interface cable. After the injection protocol has been
communicates with Main Control Unit communications interface van p communicates with Man Control ont Contribution of the lead screw ram. The ram pushes the push-rood of set, the Powernead performs the life.
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 POWERHEAD: The Powernead provides a means to and which will eject the contrast or normal
applying a force to the plunger of the syringe via its screw driven ram which will
1
Bunkvo-ku To PHONE
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 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.
CONSOLE: The Console is the main user interface for the REMPRESS. It provides a color graphical user interface with an overlying touchscreen for easy injection monitoring and injection setup. At the completion of an injection 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.
The system is designed to deliver a variety of injection protocols. The REMPRESS 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 REMPRESS contrast delivery system to the predicate devices the Liebel-Flarseim's Angiomat Illumena and Angiomat 6000. The REMPRESS is substantially equivalent to the predicate devices. The REMPRESS injector system safely and effectively injects contrast or saline solutions as desired by the user.
2
Nemoto
NEMOTO KYORINDO CO., LTD.yo 113-0033 Japan
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
TELEFHONE +81-3-5842-8571
FACSIMILE
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
TELEPHONE +81-3-5842-8571
FACSIMILE +81-3-5842-8589
| Characteristic/
Feature | Angiomat 6000
(Predicate device) | Angiomat Illumena
(Predicate Device) | REMPRESS
(New Device) |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Multi-phasic Contrast
Injections | 9 phases per protocol | 4 phases per protocol | 1 phase per protocol |
| Protocol Storage | 99 protocols | 99 protocols | 20 protocols |
| X-ray/Scan Delay | 0 - 255 secs. | 0 - 300 secs. | 0 - 99 secs |
| Inject Delay | 0 - 255 secs. | 0 - 300 secs. | 0 - 99 secs |
| Inter-phase Delay | None | 0 - 300 secs. | None |
| Inject Interval | None | 0 - 300 secs. | None |
| Syringe System | 260ml, 150ml, or 125ml | 150ml or 125ml | 150ml |
| Volume Remaining | Mechanical Scale on
Powerhead | LED display on
Powerhead | LED Display on
Powerhead |
| Display | 3 to 25ml/sec | 3 to 25ml/sec | 0.5 - 2.5ml/sec |
| Filling Rate | 0.01 to 40ml/sec for
125/150ml syringe | 0.01 to 40ml/sec for
125/150ml syringe | 0.1 to 25ml/sec with
150ml syringe |
| Flow Rate | 0.01 to 59ml/sec for
260ml syringe | | |
| Pressure Limit | 100 to 1200 PSI | 75 to 1200 PSI | 50 - 1200 PSI |
| Remote Start Switch | 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 and
mechanical backup
stopper when injection
parameters are out of
specification |
| User Interface Features
- Fill / Expel Control
- Air Detection | Push button on head
Operator visual
inspection | Push button on head
Operator visual
inspection | Push button on head
Operator visual
inspection |
| - Programming Injection - Status Display | Keypad
Powerhead lights | Touchscreen
Powerhead lights | Touchscreen
Powerhead lights |
| Materials | Plastics and metals | Plastics and metals | Plastics and metals |
| Anatomical Sites | Arterial and Venous
injections | Arterial and Venous
injections | Arterial and Venous
injections |
| Intended Use Statement | The Angiomat 6000 is
designed to inject
radiopaque contrast
medium into the
vascular system for
Angiography procedures
as prescribed by
qualified health care
professionals. | 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 REMPRESS is an
intravascular injection
system intended for the
administration of
contrast media or
flushing solutions used
in conjunction with
angiographic imaging
procedures. |
| Target Population | Humans | Humans | Humans |
| Sterility | Consumables are
provided sterile | Consumables are
provided sterile | Consumables are
provided sterile |
3
2-27-20 Hongo Bunkyo-ku, Tokyo TELEPHONE +81- 3-5842-857
+81- 3-5842-8589 FACSIMILE
SUMMARY OF PERFORMANCE TESTING
SUMMARY OF PEN ORFIANCE TEBRETS
Performance testing was completed in order to verify the Many the Manager chart Penomiance testing was completed in the system as outlined in the substantial equivalence chart.
For achieving the specification parameters for the system the substantial eq or actileving the specification parameble in these values validates the substantial equivalence, procure and verification of the system daily to accuracy of delivered flow rate, volume, pressure and manual control speeds.
VOLUME
VULUME Fluid delivery of an hijector is characenza - parameter in that is has the greatest effect on image quality.
The volume delivered is the most critical parameter in that is v limit. The volune delivered is the ness and compared to the volume programmed.
During testing, the volume delivered was accurately measured the volumes within During testing, the volume delivered with and and the REMPRESS system successfully delivered the volumes within the allowable specifications.
FLOW RATE
FLOW RATE
The second most critical variable parameter in delivering fluid to a patient is the flow rate. In the event of a injections, the injection time and volume were recorded then the flow rate calculated. In the event of a injections, the injection the volume was were wowen not to accurately represent the flow rate pressure imit injection, the volune and and are and are and the internetions and more of the flow rate the data was officed from this Specification. NOTE: Pressure imit injections and only the operator measured within the allowable fanges of the e.
reduce the flow rate from the user set flow rate to maintain a constant pressure, as desired by the operator.
PRESSURE
PRESSURE
During all injections, the injector monitors the pressure in order in order to avoid failure of During all Injections, the injector moniters the p.
During an Injections, the injector moniters the progetype used in the dignbyed your and pressure imited. An upper limit is section and measured and compared to the displayed values and the symnge. Bunny tostings were within the allowable specifications.
MANUAL CONTROL SPEEDS
MANUAL CONTROL SPEEDS
The REMPRESS has two speeds for manually moving the forward or reverse key in The REMPRESS has two speeds for manadily moving the forward or reverse key in
on the Powerhead, the rams can be moved at varying speeds. Dyring tresting, speeds on the Powerhead, the rams can be niver at harfying of
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.
4
Nemoto
NEMOTO KYORINDO CO., LTD. INDINIO I O IS I OLDI (120 O Off 23-0033 Japan
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan
FACSIMILE - - TELEFHONE - - 81-3-5
TELEPHONE +81-3-5842-8571
FACSIMILE +81-3-5842-8589
CONCLUSION
CONCLUSION
The REMPRESS contrast delivery system provided its ability to perform within its specificated as a The REMPRESS Contrast delivery by stant p
result, its performance is deemed acceptable and substantially equivalent to the predicate devices.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and three human figures in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nemoto Kyorindo Co, Ltd. c/o Mr. Jim Knipfer Executive Director, Technical Center 2-12-4 Aoki, Kawaguchi Saitama, JAPAN 332-0031
OCT 2 9 2010
Re: K092896
Trade/Device Name: REMPRESS Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II (two) Product Code: DXT Dated: October 18, 2010 Received: October 25, 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 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.
6
Page 2 - Mr. Jim Knipfer
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Dma R. Viener
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
OCT 2 9 2010
Indications for Use
510(k) Number (if known): K 09 28 9 6
Device Name: REMPRESS
Indications for Use:
The contrast delivery system REMPRESS is an intravascular injection system The ountrast believe of contrast media or normal saline used in conjunction with angiographic imaging procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Diana R. Jackson
ision of Cardiovascular Devices
Page 1 of 1
510(k) Number_ko92896