(88 days)
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No
The device description and intended use focus on mechanical components (face plate, ram tip extension) for adapting a syringe to an existing injector. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a retrofit kit for an injector used to administer contrast media for diagnostic purposes; it does not directly treat a condition or disease.
No
The device is a retrofit kit for an injector system. Its purpose is to hold a syringe for injecting contrast media, which is used for diagnostic purposes, but the kit itself does not perform any diagnostic function. It is an accessory to a system used in diagnostics, but not a diagnostic device itself.
No
The device description clearly states it consists of "two accessory pieces" which are physical components (face plate and ram tip extension) for use with existing hardware (Medrad injectors). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold a syringe for injecting contrast media into the vascular system for diagnostic purposes. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) test.
- Device Description: The device is an accessory kit for an injector system used to deliver substances into the body. It does not perform any tests on biological samples outside of the body.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample analysis, or diagnostic results derived from testing biological specimens.
Therefore, the Coeur Front Load Injector Retrofit Kit is a medical device used in an in vivo diagnostic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Iniector Ram during the injection of contrast media into the vascular system for diagnostic purposes.
Product codes
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Device Description
The Coeur Front Load Retrofit Kit consists of two accessory pieces for use with Medrad MCT and MCT Plus Injector Systems and older models of Medrad injectors upgraded by Medrad to resemble the MCT and MCT Plus. The kit contains a face plate and ram tip extension that allow easy use of the Coeur 200 mL Front Load Syringe on the modified versions of Medrad injectors. This premarket notification describes the Coeur Face Plate Retrofit Kit, which is a modification of the Coeur Front Load Injector Turret, which allows use of the Coeur 200 mL Front Load Syringe on older models of Medrad injectors.
The Face Plate uses a standard bayonet mount to attach directly onto the Medrad injectorbase on the MCT and MCT Plus injectors. The ram tip extension is then attached to the existing ram tip and tightened into place to prevent slippage. Once in place, the Coeur 200 mL Front Load Syringe may be used easily on the injectors.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification data was summarized to demonstrate that the Coeur Front Load Injector Retrofit Kit components could be produced to specification. Additionally, simulated clinical usage tests showed that a Medrad injector fitted with the Retrofit Kit and the Coeur 200 mL Front Load Syringe performed as well as the Medrad injector fitted with the previously cleared Coeur Front Load Injector Turret and Coeur 200 mL Front Load Syringe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Coeur Front Load Injector Turret and Front Load Syringe, Medrad MCT and MCT Plus Injector with Front Load Syringe
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.4300 Cardiopulmonary bypass gas control unit.
(a)
Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Coeur Laboratories Inc. The logo consists of a stylized heart shape on the left, followed by the word "COEUR" in bold, sans-serif font. A registered trademark symbol is present to the right of the word. Below the word "COEUR" is the text "LABORATORIES INC." in a smaller, sans-serif font.
MAR 2 8 1997
510(k) Summary Coeur Front Load Injector Retrofit Kit December 23, 1996
| Official Contact: | James M. Clinton, Dir. Regulatory Affairs and Quality Assurance
Coeur Laboratories, Inc.
5301 Departure Drive
Raleigh, NC 27616 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Coeur Front Load Injector Retrofit Kit |
| Common Name: | Injector Face Plate |
| Classification Name: | Injector and Syringe, Angiographic |
| Predicate Devices: | Coeur Front Load Injector Turret and Front Load Syringe
Medrad MCT and MCT Plus Injector with Front Load Syringe |
Device Description:
The Coeur Front Load Retrofit Kit consists of two accessory pieces for use with Medrad MCT and MCT Plus Injector Systems and older models of Medrad injectors upgraded by Medrad to resemble the MCT and MCT Plus. The kit contains a face plate and ram tip extension that allow easy use of the Coeur 200 mL Front Load Syringe on the modified versions of Medrad injectors. This premarket notification describes the Coeur Face Plate Retrofit Kit, which is a modification of the Coeur Front Load Injector Turret, which allows use of the Coeur 200 mL Front Load Syringe on older models of Medrad injectors.
The Face Plate uses a standard bayonet mount to attach directly onto the Medrad injectorbase on the MCT and MCT Plus injectors. The ram tip extension is then attached to the existing ram tip and tightened into place to prevent slippage. Once in place, the Coeur 200 mL Front Load Syringe may be used easily on the injectors.
Intended Use:
The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Iniector Ram during the injection of contrast media into the vascular system for diagnostic purposes.
510(k) Summary Page 1 of 2
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Technological Characteristics:
Materials: The Coeur Front Load Injector Retrofit Kit contains a machined aluminum face plate, a stainless-steel ram tip, and two brass-tipped set screws.
Packaging / Sterilization: Retrofit Kit is packaged individually in a polyethylene bag inside a corrugated cardboard outer carton. The face plate does not come into contact with the fluid path during operation, and is not a sterile device.
Performance Test Data / Conclusions:
Verification data was summarized to demonstrate that the Coeur Front Load Injector Retrofit Kit components could be produced to specification. Additionally, simulated clinical usage tests showed that a Medrad injector fitted with the Retrofit Kit and the Coeur 200 mL Front Load Syringe performed as well as the Medrad injector fitted with the previously cleared Coeur Front Load Injector Turret and Coeur 200 mL Front Load Syringe.
510(k) Summary Page 2 of 2