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.

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. The three main components 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 input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that integrated in a laptop computer). The Console communicates with Main Control Unit communications interface 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.

AI/ML Overview

The provided text describes the Nemoto Kyorindo Co., Ltd. REMPRESS Contrast Delivery System and details its technical characteristics in comparison to predicate devices, along with some information about performance testing. However, it does not contain a detailed study proving device acceptance criteria in the format requested. Specifically, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical or performance study with detailed acceptance criteria and validation results as a standalone study might.

Here's a breakdown of the available information and what is missing from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly defines "acceptance criteria" by stating that performance testing was completed to verify the new device's ability to perform within its "specificated" parameters, aligning with the substantial equivalence chart. It claims the system "successfully delivered the volumes within the allowable specifications" and that measured pressures and speeds "were within the allowable specifications." However, the specific numerical limits or ranges for these "allowable specifications" are not explicitly stated as acceptance criteria.

The following table summarizes what can be inferred for "acceptance criteria" from the provided text and the general performance statements:

Acceptance Criteria (Inferred from text)	Reported Device Performance
Volume delivered accurately measured and within allowable specifications in comparison to programmed volume	Successfully delivered volumes within allowable specifications.
Flow rate consistently measured when not pressure-limited, within allowable ranges. Pressure-limited injections should reduce flow rate to maintain constant pressure as desired.	Injection time and volume recorded; flow rate calculated when not pressure-limited. Pressure-limited injections reduced flow rate as described.
Pressure monitored and within allowable specifications during injections; prototype pressure measured and compared to displayed values and syringe.	Monitored pressure was within allowable specifications.
Manual control speeds (forward/reverse, accelerator key) confirmed to be within allowable specification range.	Speeds were confirmed to be within the allowable specification range.

What's Missing:

Specific quantitative acceptance criteria (e.g., "Volume must be within ±X% of programmed volume," "Flow rate must be within Y ml/s," "Pressure must be within Z PSI"). The text only refers to "allowable specifications" without defining them.

2. Sample Size for the Test Set and Data Provenance

Missing. The document mentions "During testing" for volume, flow rate, pressure, and manual control speeds, but it does not specify the sample size for any of these tests (e.g., number of injections, number of devices tested). It also does not state the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable (or Missing). This information is typically relevant for studies involving qualitative assessments or diagnoses (e.g., medical imaging interpretation). For a device like a contrast injector, "ground truth" is established through direct physical measurements of objective technical parameters (volume, flow rate, pressure, speed) using calibrated equipment. It does not involve human expert interpretation in the same way.

4. Adjudication Method for the Test Set

Not Applicable. As "ground truth" is established by direct measurement of physical parameters, there is no expert adjudication process in this context.

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

No. The provided text describes performance testing for a medical device (contrast injector), which focuses on engineering specifications and physical performance. MRMC studies are typically used for diagnostic devices where human readers interpret medical images. This document does not describe such a study.

6. Standalone Performance Study

Yes, implied. The "SUMMARY OF PERFORMANCE TESTING" section describes tests conducted on the REMPRESS device itself to verify its performance against "specificated parameters." This constitutes standalone testing of the algorithm (or, in this case, the device's operational capabilities) as it evaluates the device's output independently, not in conjunction with human performance.

7. Type of Ground Truth Used

The ground truth for the performance testing of the REMPRESS device was established through objective physical measurements using instruments to assess parameters like:

Fluid volume delivered (compared to programmed volume).
Flow rate (calculated from recorded volume and injection time).
Pressure (monitored during injections).
Manual (ram) control speeds.

8. Sample Size for the Training Set

Not applicable (or Missing). The REMPRESS is a mechanical/electronic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Performance testing validates the device's operational parameters rather than training a model.

9. How Ground Truth for the Training Set Was Established

Not applicable. As a non-AI device, there is no "training set" for which ground truth would be established.

In summary: The provided document is a 510(k) summary, which aims to demonstrate substantial equivalence through technical comparisons and a high-level summary of performance testing. It lacks the granular detail of a full study report that would typically include specific acceptance criteria, comprehensive methodology (including sample sizes and data provenance), and detailed results. The device's "performance is deemed acceptable and substantially equivalent to the predicate devices" based on the unspecified "allowable specifications."

Summary

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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

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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.

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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 ContrastInjections	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 onPowerhead	LED display onPowerhead	LED Display onPowerhead
Display	3 to 25ml/sec	3 to 25ml/sec	0.5 - 2.5ml/sec
Filling Rate	0.01 to 40ml/sec for125/150ml syringe	0.01 to 40ml/sec for125/150ml syringe	0.1 to 25ml/sec with150ml syringe
Flow Rate	0.01 to 59ml/sec for260ml 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 whenInjection parameters areout of specification	Electrical stop wheninjection parameters areout of specification	Electrical stop andmechanical backupstopper when injectionparameters are out ofspecification
User Interface Features- Fill / Expel Control- Air Detection	Push button on headOperator visualinspection	Push button on headOperator visualinspection	Push button on headOperator visualinspection
- Programming Injection- Status Display	KeypadPowerhead lights	TouchscreenPowerhead lights	TouchscreenPowerhead lights
Materials	Plastics and metals	Plastics and metals	Plastics and metals
Anatomical Sites	Arterial and Venousinjections	Arterial and Venousinjections	Arterial and Venousinjections
Intended Use Statement	The Angiomat 6000 isdesigned to injectradiopaque contrastmedium into thevascular system forAngiography proceduresas prescribed byqualified health careprofessionals.	The Angiomat Illumenais designed to injectradiopaque contrastmedium into thevascular system forAngiography and CTprocedures as prescribedby qualified health careprofessionals.	The contrast deliverysystem REMPRESS is anintravascular injectionsystem intended for theadministration ofcontrast media orflushing solutions usedin conjunction withangiographic imagingprocedures.
Target Population	Humans	Humans	Humans
Sterility	Consumables areprovided sterile	Consumables areprovided sterile	Consumables areprovided sterile

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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.

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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.

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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.

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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

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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

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.