(18 days)
The Contrast Delivery System – Dual Shot Alpha 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).
Contrast Delivery System -- Dual Shot Alpha 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-siice CT scanners. The Dual Shot Alpha 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 100mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. Dual Shot Alpha consists following components; Injector head, Console, Power Supply, and Options (Hand Switch).
This document is a 510(k) summary for the NEMOTO KYORINDO DUAL SHOT - CONTRAST DELIVERY SYSTEM (K062168). It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data or clinical study results as would be typical for a new device requiring rigorous acceptance criteria and clinical trials.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not present in this type of submission. This document primarily addresses safety and effectiveness through adherence to recognized standards and comparison to a legally marketed predicate device.
Here's a breakdown of what can be extracted and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (intravascular injection of contrast media and saline for CT) | "Same" (as predicate) |
| Design/Technology | Substantially equivalent in materials and technology to predicate | "Same or substantially equivalent materials and technology" |
| Electrical Safety | Conformance to IEC60601-1 (1988) | Tested in conformance |
| Medical Electrical Systems Safety | Conformance to IEC60601-1-1 (2000) | Tested in conformance |
| Electromagnetic Compatibility (EMC) | Conformance to IEC60601-1-2 (2001) | Tested in conformance |
| Programmable Electrical Medical Systems Safety | Conformance to IEC60601-1-4 (1996) | Tested in conformance |
| Quality Management Systems | Conformance to ISO13485 (2003) | Tested in conformance |
| Risk Management | Conformance to ISO14971 (2000) | Tested in conformance |
| Biocompatibility | Not applicable (device does not include a sterile syringe) | Biocompatibility testing not performed |
| Functional Equivalence | Functional parameters (e.g., phases, protocols, flow rate, pressure limit) as good as or better than predicate | Detailed comparison table shows functional equivalence or minor improvements (e.g., B-head syringe size change from 50mL to 100mL, corresponding volume change) |
Note: For this type of submission, "acceptance criteria" are implicitly met by demonstrating conformance to recognized standards and achieving substantial equivalence to the predicate device for all comparative features.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: This document is a 510(k) premarket notification primarily demonstrating substantial equivalence through engineering comparisons and adherence to recognized standards. It does not describe a "test set" in the sense of clinical data or performance evaluation on patient samples. The "testing" refers to verification against engineering standards.
- Data Provenance: Not applicable as no clinical data or test set in that context is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: No clinical test set requiring expert-established ground truth is mentioned. The ground truth for this device's safety and effectiveness is established by its conformance to international standards and its functional equivalence to a legally marketed predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This device is a contrast delivery system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided: This is a mechanical/electronic medical device for injecting contrast. It does not have an "algorithm only" performance or a human-in-the-loop component in the context of an AI device. Its performance is assessed by its mechanical and electronic functions meeting specified parameters and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Standards and Predicate Performance: For this device, the "ground truth" for its safety and effectiveness is primarily its adherence to recognized international safety and performance standards (IEC, ISO) and its documented functional equivalence to the legally marketed predicate device. There is no clinical "ground truth" (like pathology or outcomes data) presented for this type of submission.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/machine learning product; it does not have a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no training set, this question is not applicable.
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K062168
p. 1 of 4
AUG 1 8 2006
510(k) SUMMARY NEMOTO KYORINDO DUAL SHOT - CONTRAST DELIVERY SYSTEM
DATE 510(k) SUMMARY PREPARED: March 24, 2006
| OFFICIAL CONTACT: | Toshio KanetakaDirector of Technical CenterNemoto Kyorindo CO., LTD.2-12-4 Aoki Kawaguchi-shiSaitama 332-0031, JapanTEL : +81 48 250 3255FAX : +81 48 250 3256 |
|---|---|
| CLASSIFICATION NAME(S): | Angiographic Injector with Syringe |
| DEVICE CLASSIFICATION: | Class II |
COMMON NAME: Powered Injector with Syringe
PROPRIETARY NAME:
PREDICATE DEVICE:
DUAL SHOT -- CONTRAST DELIVERY SYSTEM from NEMOTO KYORINDO K052633
Contrast Delivery System - Dual Shot Alpha
INTENDED USE:
The Contrast Delivery System – Dual Shot Alpha 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:
Contrast Delivery System -- Dual Shot Alpha 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-siice CT scanners. The Dual Shot Alpha 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 100mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. Dual Shot Alpha consists following components;
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Injector head
Injector 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 syringe with contrast media or saline. Injector head is composed of operation indicator LED, switches for manual operation, start-switch to start influsion and stop-switch to stop infusion. Injector head detects injection conditions and transmits the Injector 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 setIdisplay 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
-
ロ 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:
Contrast Delivery System - Dual Shot Alpha 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 ray computed tomography (i.e. "CT").
Contrast Delivery System -- Dual Shot Alpha consists of three main components like the predicate device: a Injector head, a Console, and a Power Supply. Both the Dual Shot Alpha and predicate device consist of the same or substantially equivalent materials and technology. They are motor driven, electromechanical devices that are controllect by software.
Below is a table that compares the predicate device to the proposed Contrast Delivery System - Dual Shot Alpha.
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K062168 p. 3 = fy
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| Feature | Proposed Device:Contrast Delivery System -Dual Shot Alpha | Predicate Device:DUAL SHOT - CONTRAST DELIVERYSYSTEM |
|---|---|---|
| Intended Use | The Contrast Delivery System - Dual ShotAlpha is an intravascular injection systemintended for the administration of ionic andnon-ionic contrast media and saline usedin conjunction with computed x-raytomography (CT). | same |
| Single or Dual SyringeSystem | Dual syringe model | Same |
| Information Display | Color LCD | Same |
| Programming Keys | Non-dedicated keys - software determined | Same |
| Touch Screen | Yes | Same |
| Multi-Phase | 1-5 Phases per injection | Same |
| Arming Modes | Single | Same |
| Protocol Storage | 125 protocols | Same |
| Capability | ||
| Hold Capability | Until user operate. | Same |
| Scan Delay | 1 - 300 seconds | Same |
| Safety Stop Mechanism | Multi layered software stops with backupmonitoring. | Same |
| Syringe System | A-head: 200mL or 100mL syringeB-head: 100mL syringe | A-head: 200mL or 100mL syringeB-head: 50mL syringe |
| Programmed Volume | A-head: 1 to 200mL or 1 to 100mL(depending on syringe size)B-head: 1 to 100mL | A-head: 1 to 200mL or 1 to 100mL(depending on syringe size)B-head: 1 to 50mL |
| Volume RemainingReadout | Graphic and numeric on LCD | Same |
| Fill Rate | Variableup to 10mL /sec | Same |
| Flow Rate | 0.1mL/sec to 10mL/sec | Same |
| Programmable PressureLimit | Settablefrom 10 to 300PSI | Same |
| Pause | Programmable -1 sec to 300 secondsin 1sec increments | Same |
| Autofill | Fill rate 1.5mL/sec | Same |
| Retract Control | No | Same |
| Remote Start Switch | Yes | Same |
| Pressure Graph | Yes | Same |
| Syringe Sensing | Yes | Same |
| Test Injection | Yes | Same |
| Syringe Heat Maintainer | Yes | Same |
.
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PERFORMANCE DATA:
No performance standards have been established for Angiographic injectors under section 514 of the FD&C Act.
Contrast Delivery System - Dual Shot Alpha 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 IEC60601-1-4 (1996) Medical electrical equipment -- Part 1-4: General 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 Contrast Delivery System - Duar Shot Alpha does not include a sterile syringe.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2006
TUV Rheinland of North America, Inc. c/o Ms. Tamas Borsai 12 Commerce Road Newton, CT 06470
Re: K062168
Contrast Delivery System - Dual Shot Alpha Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: II Product Code: DXT Dated: July 26, 2006 Received: July 31, 2006
Dear Ms. Borsai:
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 - Ms. Tamas Borsai
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
FOR
Sincerely vours.
Q.B.Me
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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Indications for Use
Attachment 1b Page 1 of 1
510(k) Number (if known): Kolo2 168
Contrast Delivery System - Dual Shot Alpha Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Contrast Delivery System – Dual Shot Alpha is an intravascular injection system The Contrast Delivery System - Dual Choc films is and non-ionic contrast media and saline used in
intended for the administration of ionic and non-ionic contrast media and sa conjunction with computed X-Ray tomography (CT).
Prescription Use X (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)
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_ 6062168
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.