(156 days)
Not Found
No
The device description and performance studies focus solely on the mechanical adaptation of a syringe to an existing injector system. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML.
No.
The device is an adapter for an angiographic injector, which is used to inject contrast media for diagnostic imaging, not for treating a condition.
No
This device is an adapter for an angiographic injector, facilitating the use of specific syringes with certain injectors. Its function is mechanical adaptation for injecting contrast media, not diagnosing conditions or processing diagnostic data.
No
The device description clearly states it is a "Front Load Adapter" and includes a "component that affixes to the ram of the power injector." This describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to adapt an angiographic injector for use with a specific type of syringe. This is a mechanical adaptation for a device used to inject contrast media into the patient for imaging purposes.
- Device Description: The description clearly states it's an adapter for a power injector and syringe used to inject contrast media into the heart and vessels. This is an in vivo procedure (performed within a living organism).
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with patient specimens in this way.
- Input Imaging Modality: The input is related to the imaging modality (x-ray photography), which is used to visualize the contrast media after it has been injected into the patient.
- Anatomical Site: The anatomical site (heart, great vessels, coronary arteries) is where the contrast is injected, not where a specimen is collected for in vitro analysis.
The device is an accessory for an angiographic injector system, which is an in vivo medical device used for diagnostic imaging procedures.
N/A
Intended Use / Indications for Use
For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes
Product codes
DXT
Device Description
The proposed device is a Front Load Adapter for Liebel-Flarsheim Optivantage DH Injector. As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a highpressure injector which is used to inject contrast media into the heart, great vessels. and coronary arteries to study the heart and vessels by x-ray photography. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, great vessels, and coronary arteries
Indicated Patient Age Range
Not Found
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
Nonclinical Tests Submitted: Verification of functional performance was achieved which included that the adapter can be properly installed, the syringe will properly load into the adapter, and that the syringe, with the adapter, can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors. Such testing was conducted for the design for use on the Liebel-Flarsheim Optivantage DH Injectors. The installation, the loading, and the injection were all successfully completed. The equipment performed as intended.
Clinical Tests Submitted: NA
Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions drawn from the nonclinical tests demonstrate that the device is as safe and as effective as the legally marketed predicate devices identified.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 3 0 2014 K133600
Coeur, Inc. Front Load Adapter for CT Injector
ﻣﺮ ﻣ
510(k) Summary
| 1. | Submitter: | Name: | Coeur, Inc. |
|---|---|---|---|
| Address: | 100 Physicians Way, Suite 200 | ||
| Lebanon, TN 37090 | |||
| Owner/Operator Number: 9038672 | |||
| Phone: | (615) 547-7923 (Corporate Office) | ||
| Fax: | (615) 547-7937 (Corporate Fax) | ||
| Contact: | Debra F. Manning, Director, Q & RA | ||
| Date: | November 22, 2013 |
| 2. | Device: | Trade/Proprietary Name: | Front Load Adapter for CT Injector for use |
|---|---|---|---|
| with Coeur Front Load Syringe | |||
| Common/Usual Name: | Adapters for Power Injectors | ||
| Classification Name: | Accessory, Injector and Syringe, | ||
| Angiographic |
Legally Marketed Devices to which Substantial Equivalence is claimed: ട്.
Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors (K070798) - Coeur
Medrad Envision CT Injector System, Medrad, K993728
Optivantage DH Injector System with Enhanced Communication (K063503) - Mallickrodt Inc., Liebel-Flarsheim
-
- Device Description: The proposed device is a Front Load Adapterfor Liebel-Flarsheim Optivantage DH Injector. As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a highpressure injector which is used to inject contrast media into the heart, great vessels. and coronary arteries to study the heart and vessels by x-ray photography. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe.
-
- Intended Use of Device: For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes
1
-
Summary of Technological Characteristics As Compared to Predicate Devices: The 6. intended use, the method of use, and the materials of the proposed device are the same as those identified for the legally-marketed predicate Coeur devices as appropriate to the injector. Like the legally-marketed predicate injectors, the proposed device allows for the intended use (injecting contrast media, saline, or other diagnostic fluids into patients) and is made with materials appropriate for its function. The proposed devices position the Coeur Front Load Syringe in front of the ram for use with the injector. Any differences in syringe placement are not significant as the ram is advanced to move the plunger to the full forward position for filling, enabling use with and like the predicate device.
If Substantial Equivalence was based on an Assessment of Ferformance Data, the following information is also provided: -
Nonclinical Tests Submitted: Verification of functional performance was achieved 1. which included that the adapter can be properly installed, the syringe will properly load into the adapter, and that the syringe, with the adapter, can be filled and used to inject contrast, saline, or other diagnostic thuids into the patient without affecting the function of the power injectors.
Such testing was conducted for the design for use on the Liebel-Flarsheim Optivantage DH Injectors. The installation, the loading, and the injection were all successfully completed. The equipment performed as intended. -
- Clinical Tests Submitted: NA
-
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions drawn from the nonclinical tests demonstrate that the device is as safe and as effective as the legally marketed predicate devices identified.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text surrounding the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenus Document Control Center - WO66-Good Silver Spring, MI) 20993-0002
April 30. 2014
Coeur, Inc. Ms. Debra Manning Director, Quality & Regulatory Alfairs 100 Physicians Way, Suite 200 Lebanon. TN 37090
રિંદ: K133600
Trade/Device Name: Frontload Adapter for CT Injector Regulation Number: 21 CFR 870.1650 Regulation Name: Injector and Syringe, Agiographic Regulatory Class: Class II Product Code: DXT Dated: April 10. 2014 Received: April 11. 2014
Dear Ms. Manning:
We have reviewed vour 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 androval 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 (reporting of medical devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in
3
Page 2 - Ms. Debra Manning
the quality systems (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Front Load Adapter for CT Injector
Indications For Use:
For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes
Prescription Use V (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)
Bram D. Zuckerman -S 2014.04.30 06:41:48 -04'00'
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