(21 days)
The Dual Shot – Contrast Delivery System 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).
DUAL SHOT - CONTRAST DELIVERY SYSTEM is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-slice CT scanners. The DUAL SHOT has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 50mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. DUAL SHOT consists following components; Injector head, Console, Power Supply, Options (Hand Switch).
The Nemoto Kyorindo DUAL SHOT - CONTRAST DELIVERY SYSTEM is an intravascular injection system designed for administering ionic and non-ionic contrast media and saline during computed X-ray tomography (CT) procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance studies with specific statistical acceptance criteria for diagnostic accuracy.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "No performance standards have been established for Angiographic injectors under section 514 of the FD&C Act." Therefore, there isn't a table of specific performance acceptance criteria. Instead, the device's acceptability is based on conformance to recognized safety and quality standards and demonstrating substantial equivalence to a predicate device through feature comparison.
The "reported device performance" in this context refers to the device meeting general safety and electrical standards, and its functional specifications being comparable to the predicate.
| Acceptance Criterion (Implicit - Conformance to Standards & Equivalence) | Reported Device Performance |
|---|---|
| Safety and Electrical Standards Conformance: | DUAL SHOT - CONTRAST DELIVERY SYSTEM has been tested in conformance with: - IEC60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety- IEC60601-1-1 (2000) Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems- IEC60601-1-2 (2001) Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests- IEC60601-1-4 (1996) Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| Quality Management System: | Conformance to ISO13485 (2003) Medical devices - Quality management systems - Requirements for regulatory purposes |
| Risk Management: | Conformance to ISO14971 (2000) Medical devices - Application of risk management to medical devices |
| Functional Equivalence to Predicate Device: | The device's features (Intended Use, Syringe System, Flow Rate, Pressure Limit, etc.) were compared to the Stellant CT Injector System (K023183 and K033881) and found to be "the same or substantially equivalent materials and technology." Specific differences and similarities are listed in the comparison table, but these are for demonstrating equivalence, not for meeting pre-defined performance thresholds. |
| Biocompatibility: | Not applicable/not performed as the device does not include a sterile syringe. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy or a similar performance metric. The "testing" referred to is against electrical, safety, and quality standards in a laboratory setting. Therefore, information about test set sample size, data provenance, or retrospective/prospective nature is not provided because such a study was not conducted or required for this type of submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is also not applicable. As explained above, there isn't a "test set" for which ground truth would need to be established by experts for diagnostic or similar performance evaluation. The device's safety and functionality were assessed against engineering and electrical standards.
4. Adjudication Method for the Test Set:
Not applicable, as there was no test set requiring expert adjudication for performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document does not mention any studies evaluating human reader performance with or without AI assistance, as the device is an Angiographic injector, not an AI-powered diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
No, a standalone algorithm performance study was not done. The device is a physical medical device (an injector), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The concept of "ground truth" as typically used in the context of diagnostic performance (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "truth" for this device's evaluation largely refers to conformance to the specified engineering, safety, and quality standards (e.g., did it meet the described voltage tolerances, did it operate within specified flow rates, etc.).
8. The Sample Size for the Training Set:
Not applicable. The DUAL SHOT - CONTRAST DELIVERY SYSTEM is a hardware device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this device.
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OCT 17 2005
510(k) SUMMARY NEMOTO KYORINDO DUAL SHOT - CONTRAST DELIVERY SYSTEM
DATE 510(k) SUMMARY PREPARED: July 26, 2005
| OFFICIAL CONTACT: | Toshio Kanetaka |
|---|---|
| Director of Technical Center | |
| Nemoto Kyorindo CO., LTD. | |
| 2-12-4 Aoki Kawaguchi-shi | |
| Saitama 332-0031, Japan | |
| TEL: +81 48 250 3255 | |
| FAX: +81 48 250 3256 |
CLASSIFICATION NAME(S): Angiographic Injector with Syringe
DEVICE CLASSIFICATION: Class II
COMMON NAME:
PROPRIETARY NAME: DUAL SHOT - CONTRAST DELIVERY SYSTEM
Powered Injector with Syringe
PREDICATE DEVICE: Stellant CT Injector System from MEDRAD K023183
Stellant CT Injector System with Imaging System Interface Module from MEDRAD K033881
INTENDED USE: The DUAL SHOT - CONTRAST DELIVERY SYSTEM 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).
DESCRIPTION OF DEVICE:
DUAL SHOT - CONTRAST DELIVERY SYSTEM is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-slice CT scanners. The DUAL SHOT has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 50mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. DUAL SHOT consists following components;
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Iniector head
Iniector head provides accurate, automatic delivery of contrast media by two electromechanically driven actuators. Sterile empty-syringes or pre-filled syringes can be set onto the Injector head. For the sterile empty-syringes, Injector head provides auto-return function to fill the svringe with contrast media or saline. Injector head is composed of operation indicator LED, switches for manual operation, start-switch to start infusion and stop-switch to stop infusion. Injector head detects injection conditions and transmits the Iniector head status information to the console.
। Console
The console takes up very little space on a control desk, and consists of TFT LCD display and touch panel interface to set/display various injections set by an operator. The operator can set injection pressure, time, volume, flow rate and a patient examination region of interest.
Power Supply ।
The power supply is intended for placement on the floor around the console of a CT scanner. The power supply consists of a transformer and appliance inlet, as a provide power source to the injector head and console.
- Options ।
- Hand Switch
Hand Switch is connected to the console and consists of start and stop switches to start/stop injection according to the protocols already set on the console. Hand Switch provides LEDs with an operator to display scan time and injection state.
SUBSTANTIAL EQUIVALENCE:
DUAL SHOT - CONTRAST DELIVERY SYSTEM maintains the same intended use as the predicate device. It is intended for the specific purpose of injecting contrast media and saline solution into a patient's vascular system to obtain diagnostic images in X-rav computed tomography (i.e. "CT").
DUAL SHOT - CONTRAST DELIVERY SYSTEM consists of three main components like the predicate device: a Iniector head, a Console, and a Power Supply. Both the DUAL SHOT and predicate device consist of the same or substantially equivalent materials and technology. They are motor driven, electromechanical devices that are controlled by software.
Below is a table that compares the predicate device to the proposed DUAL SHOT -CONTRAST DELIVERY SYSTEM.
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| Feature | Proposed Device:DUAL SHOT – CONTRASTDELIVERY SYSTEM | Predicate Device:Stellant CT Injector System(K023183 and K033881) |
|---|---|---|
| Intended Use | The DUAL SHOT CONTRAST DELIVERY SYSTEM is an intravascular injection systemintended for the administration of ionic andnon-ionic contrast media and saline used inconjunction with computed x-ray tomography(CT). | Intended to be used for the specific purpose ofinjecting intravenous contrast media intohumans for diagnostic studies in computedtomography (CT) applications. |
| Single or Dual SyringeSystem | Dual syringe model | Single and dual syringe models |
| Information Display | Color LCD | Same |
| Programming Keys | Non-dedicated keys – software determined | Same |
| Touch screen | Yes | Same |
| Multi-Phase | 1-5 Phases per injection | 1-6 Phases per injection |
| Arming Modes | Single | Same |
| Protocol StorageCapability | 125 protocols | 32 protocols |
| Hold capability | Until user operate. | 20 minutes max. |
| Scan Delay | 1 – 300 seconds | Same |
| Safety Stop Mechanism | Multi layered software stops with backupmonitoring. | Electrical stop with a software backup system |
| Syringe System | A-head: 200mL or 100mLsyringeB-head: 50mL syringe | Dual syringe model: two 200mL syringe |
| Programmed Volume | A-head: 1 to 200mL or 1 to 100mL(depending on syringe size)B-head: 1 to 50mL | 1 to 200mL |
| Volume RemainingReadout | Graphical and numeric on LCD | LED on injector head; graphical and numericon LCD |
| Fill Rate | Variable up to 10mL /sec | Same |
| Flow Rate | 0.1mL/sec to 10mL/sec | Same |
| ProgrammablePressure Limit | Settable from 10 to 300PSI | 325PSI default, user settable 50 to 300 PSI |
| Pause | Programmable – 1 sec to 300 seconds in 1 secincrements | Programmable – 1 sec to 900 sec in 1secincrements |
| Autofill | Fill rate 1.5mL/sec | Fill rate 4mL/sec |
| Retract Control | No | Yes (Automatic) |
| Remote Start Switch | Yes | Yes |
| Pressure Graph | Yes | Yes |
| Syringe Sensing | Yes | Yes |
| Autoload | No | Yes |
| Auto Dock/Retract/Advance | No | Yes; user-selectable autodock and advance;user-selectable auto-retract |
| Protocol Lock/ RemoteArming | No | Yes |
| Remote Check for Air(from Head) | No | Yes |
| Test Injection | Yes | Yes |
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PERFORMANCE DATA:
No performance standards have been established for Angiographic injectors under section 514 of the FD&C Act.
DUAL SHOT CONTRAST DELIVERY SYSTEM has been tested in conformance with the following recognized standards, and is substantially equivalent to the predicate device:
IEC60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety - This is the general standard for medical electrical equipment IEC60601-1-1 (2000) Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC60601-1-2 (2001) Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
Medical electrical equipment - Part 1-4: General IEC60601-1-4 (1996) requirements for safety - Collateral Standard: Programmable electrical medical systems ISO13485 (2003) Medical devices - Quality management systems - Requirements for regulatory purposes
ISO14971 (2000) Medical devices - Application of risk management to medical devices
Biocompatibility testing has not been performed since DUAL SHOT - CONTRAST DELIVERY SYSTEM does not include a sterile syringe.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tuv Rheinland of North America, Inc. c/o Mr. Tamas Borsal Manager, Medical Division 12 Commerce Road Newton, CT 06470
Re: K052633
Dual Shot - Contrast Delivery System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: DXT Dated: September 20, 2006 Received: September 26, 2005
Dear Mr. Borsal:
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 such 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. Tamas Borsal
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); 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. 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 Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dina R. Vichner
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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Attachment 1b Page 1 of 1
510(k) Number (if known)
: KC52633
Device Name
:Dual Shot - Contrast Delivery System
Indications For Use:
The Dual Shot – Contrast Delivery System is an intravascular injection system intended for the administration of ionic and not in intrarasonia injocan system interior in
computed Your and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).
(Please DO NOT WRITE BELOW THE LINE-CONTIUNUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
R. Vclines
(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K052633
§ 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.