(195 days)
Not Found
No
The device description and performance studies focus on mechanical adaptation and functional performance, with no mention of AI or ML.
No
The device is an adapter for angiographic power injectors and syringes, designed to facilitate the use of specific syringes with existing injectors. It does not directly provide therapy; rather, it enables the delivery of diagnostic contrast materials for imaging.
No
The device is an adapter for power injectors used to deliver contrast material. It does not perform any diagnostic function itself, but rather facilitates a diagnostic procedure by enabling the use of specific syringes with existing injectors.
No
The device description explicitly states it is a "unit designed to install onto legally marketed power injectors" and includes physical components like a "component that affixes to the ram" and a "plastic lever component." This indicates it is a hardware device, not software-only.
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 power injectors for use with syringes to inject contrast material into the body for imaging purposes. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside of a living organism, typically on biological samples).
- Device Description: The description clearly states the device is used to inject contrast material into the heart, great vessels, and coronary arteries to study them by x-ray photography. This is a medical imaging procedure, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is an accessory for medical imaging equipment used for diagnostic purposes, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Coeur, Inc. Adapters are for use in adapting CT and/or Angiographic power injectors for use with Coeur syringes.
for use in adapting CT and/or Angiographic power injectors for use with Coeur Syringes
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
As defined by 21 CFR 870.1650, 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. 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. It also includes a plastic lever component that allows the injector to be used more like the existing Mallinckrodt injector and will also be sold separately as a replacement part for that injector.
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 (inferred from the description of angiographic injector and syringe)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests Submitted: Verification of functional performance has been performed to ensure that the adapter can be properly installed, the syringe will properly load into the injector, and that the syringe can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors. The installation, the loading, and the injection were all successfully completed. The equipment performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K965214, K960965, K912944, K993728, K032920, K924116
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
് 2007 OCI A
Coeur, Inc.
Coeur Medical, a division of Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors
510(k) Summary
| 1. | Submitter: | Name: | Coeur Medical, a division of Coeur, Inc. |
|---|---|---|---|
| Address: | 209 Creekside Drive | ||
| Washington, NC 27889 | |||
| Phone: | (615) 547-7923 (Corporate Office) | ||
| Fax: | (615) 547-7937 (Corporate Fax) | ||
| Contact: | Debra F. Manning, VP, Q & RA | ||
| Date: | October 2, 2007 |
- Device: Trade/Proprietary Name: Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors Common/Usual Name: Adapter for Power Injectors Classification Name: Accessory, Injector and Syringe, Angiographic
3. Legally Marketed Devices to which Substantial Equivalence is claimed:
Coeur Front Load Injector Retrofit Kit (K965214) - Coeur
Front Load Injector Turret and 200ml Front Load Syringe (K960965) - Coeur
CT 8000 Digital Injection System (K912944) - Mallinckrodt Group, Inc.
Medrad Envision CT Injection System (K993728) - Medrad
Coeur Injector Adapter/Pressure Jacket (K032920) - Coeur
Medrad MCT, MCT Plus Injector/Medrad Front Load (K924116) - Medrad
4. Device Description:
As defined by 21 CFR 870.1650, 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. 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
1
injector to adapt it to fit the plunger of the Coeur syringe. It also includes a plastic lever component that allows the injector to be used more like the existing Mallinckrodt injector and will also be sold separately as a replacement part for that injector.
-
- Intended Use of Device: The Coeur, Inc. Adapters are for use in adapting CT and/or Angiographic power injectors for use with Coeur syringes.
| Technological
Characteristics | Proposed Device | Coeur
Devices | Medrad
Devices | Mallinckrodt
(LF) Device | Rationale for Applicable
Differences |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in adapting
power injectors for use
with Coeur syringes to
enable the intended
use of the power
injectors (injection of
contrast, saline, or
other diagnostic fluids
into a patient) to be
accomplished using
Coeur syringes. | Same | Syringe based
fluid delivery
systems for
injecting
contrast into
patient. | Injects contrast
into vascular
system for
angiographic
or CT as
prescribed. | NA - The proposed device does
not alter the intended use (injecting
contrast, saline, or other diagnostic
fluid into patient) of the power
injectors upon which it will be
installed. |
| Sterile | No | No | No | No | NA - The disposable syringe is
sterile, not the adapters/power
injectors with which they are used. |
| Components | Combinations of steel
and anodized
aluminum, o-rings and
plastic components
including levers with
magnets. | Steel and
anodized
aluminum
and o-rings
or plastic | Injector system
includes
hardware and
software | Injector system
including
hardware and
software | The proposed device incorporates
a plastic lever to enable use of the
syringe system similar to a feature
available with some Mallinckrodt
equipment. Otherwise, the
differences are not applicable as
the components are durable for
their intended use. |
| Connection
Method | Mechanically affixed
to injector in a secure
manner (i.e., affixed
with bolts, screws,
and/or dowel and roll
pins.). | Same | NA | NA | NA |
| Function | Holds disposable
syringe in position
in front of injector
ram. | Same | Same | Same | NA |
Summary of Technological Characteristics As Compared to Predicate Devices: 6.
If Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:
-
- Non-clinical Tests Submitted: Verification of functional performance has been performed to ensure that the adapter can be properly installed, the syringe will properly load into the injector, and that the syringe can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors.
2
The installation, the loading, and the injection were all successfully completed. The equipment performed as intended.
Clinical Tests Submitted: NA 2.
- Conclusions Drawn from Non-clinical and Clinical Tests Submitted: The 3. primary difference between the proposed Coeur devices and the currently marketed Coeur devices is that the proposed device will be used upon injectors for which it is designed to fit - the form and function will not be significantly different. The proposed design will also allow components that may be used with other power injectors, including, for example, the incorporation of a lever that allows the system with the Coeur syringe to use a "Used Syringe Alarm" feature available with the Mallinckrodt system. The lever will also be available for sale separately as a replacement component. Coeur has expanded its business to include the offering of service for power injectors in its new service division and replacement components are needed for this division. This lever is one such replacement component.
The primary difference between the proposed devices and legally marketed power injectors is that it works in conjunction with the power injectors without changing their intended use, to allow use of the Coeur syringes.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coeur Medical a division of Coeur, Inc. c/o Ms. Debra F. Manning Vice President, Quality & Regulatory Affairs 209 Creekside Drive Washington, NC 27889
2007
Re: K070798
Trade/Device Name: Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Power Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: August 31, 2007 Received: September 4, 2007
Dear Ms. Manning:
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.
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
4
Page 2 - Ms. Debra F. Manning
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Sincerely yours,
C
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K070798
Coeur, Inc. Adapters/Pressure Jackets for CT and/or Angiographic Device Name: Power Injectors
Indications For Use:
for use in adapting CT and/or Angiographic power injectors for use with Coeur 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)
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