(73 days)
Unknown
The description mentions the software "computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration." While this involves computation and potentially complex algorithms, the summary does not explicitly state the use of AI or ML, nor does it provide details about training or test data which are typical indicators of ML. It could be based on rule-based algorithms or other computational methods.
No
The device is described as an "injector system" used for injecting contrast media for "diagnostic studies." It does not claim to treat or cure any medical condition.
No
Explanation: The device is an injector system for delivering contrast media for diagnostic studies, not a diagnostic device itself. The P3T CardiacFlow accessory generates injection protocols and scan timing to aid the diagnostic process, but it does not perform diagnosis.
No
The device described is the MEDRAD Stellant CT Injector System with the P3T CardiacFlow software accessory. While the P3T CardiacFlow is a software component, the overall device is a syringe-based fluid delivery system, which is a hardware device. The software is an accessory to this hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The MEDRAD Stellant CT Injector System with P3T CardiacFlow is a device that injects contrast media into the human body for diagnostic imaging (CT). It is a delivery system used in vivo (within the living body).
- Intended Use: The intended use clearly states the injection of contrast media into humans for diagnostic studies in CT applications. This is an in vivo procedure.
- Device Description: The description reinforces that it is a syringe-based fluid delivery system for delivering contrast media during CT procedures.
While the device is used in conjunction with diagnostic imaging, its function is to administer a substance to the patient, not to analyze a sample from the patient. Therefore, it falls under the category of a medical device used for diagnostic purposes, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
The Stellant P3T CardiacFlow software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition.
The Stellant P3T CardiacFlow software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.
Product codes
DXT
Device Description
MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. P3T CardiacFlow is an optional, password-enabled accessory. The injector system, when used with P3T CardiacFlow, maintains the same intended use, same operational parameters, and same labeling (with the addition of a P3T CardiacFlow operations manual). This device is also used in the same manner as the predicate devices.
The MEDRAD Stellant CT Injector System with P3T CardiacFlow is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. MEDRAD Stellant CT Injector System with P3T CardiacFlow maintains the same intended use, operational parameters, and labeling as the MEDRAD Stellant CT Injector System, with the addition of P3T CardiacFlow Instructions For Use. The P3T CardiacFlow accessory provides the convenience of generating patient-specific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists. Stellant CT Injector System with P3T CardiacFlow is used in the same manner as the predicate device (Stellant CT Injector System without P3T CardiacFlow).
The Stellant safety architecture has not been modified nor impacted; additionally every injection protocol must be approved and locked by the practitioner. The practitioner always has the option of modifying or deleting the P3T CardiacFlow suggested protocol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
MEDRAD Stellant CT Injector System with Imaging System Interface Module (K033881), OptiVantage DH Injection System (K042744)
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.
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Image /page/0/Picture/0 description: The image shows the word "MEDRAD" in a stylized font. Below the word "MEDRAD" is the phrase "Performance. For life.", also in a stylized font. The word "MEDRAD" is in all caps and appears to be the name of a company or product.
510(K) SUMMARY
| OFFICIAL CONTACT: | Lisa M. Casavant
Sr. Regulatory Affairs Specialist
MEDRAD, Inc.
One MEDRAD Drive
Indianola, PA 15051
(412) 767-2400 ext. 3694 | DEC 21 2007 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic | |
| COMMON NAME(S): | Powered Injector with Syringe | |
| PROPRIETARY NAME: | MEDRAD Stellant CT Injector System with P3T
CardiacFlow | |
| PREDICATE DEVICES: | MEDRAD Stellant CT Injector System with Imaging
System Interface Module (K033881)
OptiVantage DH Injection System (K042744)
Mallinckrodt, Inc., Liebel-Flarsheim Business | |
INTENDED USE: The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
The Stellant P3T CardiacFlow software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition.
The Stellant P3T CardiacFlow software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.
1
Image /page/1/Picture/0 description: The image shows the word "MEDRAD" in a stylized font. The word is in all caps and appears to be a logo. Below the word "MEDRAD" is the phrase "Performance. For life.", which is in a smaller font.
CONTRAINDICATIONS: Stellant P3T CardiacFlow is not intended for use in Ungated CT angiography of the Right heart, Pulmonary trunk and Pulmonary Arteries for assessment of thrombo-emboli (dedicated Pulmonary Embolism (PE) studies), for angiography of the head/neck vessels, or for peripheral angiography.
The P3T CardiacFlow feature on the Stellant CT Injector is not intended for use on patients with compromised renal or some other contrast adverse related health issue.
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE: MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. P3T CardiacFlow is an optional, password-enabled accessory. The injector system, when used with P3T CardiacFlow, maintains the same intended use, same operational parameters, and same labeling (with the addition of a P3T CardiacFlow operations manual). This device is also used in the same manner as the predicate devices.
The MEDRAD Stellant CT Injector System with P3T CardiacFlow is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
MEDRAD Stellant CT Injector System operating software has been modified to include the P3T CardiacFlow accessory. MEDRAD Stellant CT Injector System with P3T CardiacFlow maintains the same intended use, operational parameters, and labeling as the MEDRAD Stellant CT Injector System, with the addition of P3T CardiacFlow Instructions For Use. The P3T CardiacFlow accessory provides the convenience of generating patient-specific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists. Stellant CT Injector System with P3T CardiacFlow is used in the same manner as the predicate device (Stellant CT Injector System without P3T CardiacFlow).
The Stellant safety architecture has not been modified nor impacted; additionally every injection protocol must be approved and locked by the practitioner. The practitioner
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Image /page/2/Picture/0 description: The image shows the word "MEDRAD" in a bold, sans-serif font. Below the word "MEDRAD" is the phrase "Performance For Life." The text is in a smaller font size than the word "MEDRAD."
always has the option of modifying or deleting the P3T CardiacFlow suggested protocol.
A comparison of features and principles of operation between the proposed device and predicate devices is provided in Table 1 on the following page.
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Image /page/3/Picture/0 description: The image shows the word "modern" vertically on the left side of the image. On the right side of the image, there are some words in a different language. The words on the right side are stacked vertically.
Table 1: Comparison of Stellant CT Injector System with P3T Cardiact Crow Accessory to Stellant CT Injector
System with ISI Accessory and to the Mallinckrodt Opti Power Injec
| Feature | Intended Use | Predicate Device:
Stellant CT Injector System
with ISI Accessory (K033881) | Predicate Device:
Mallinckrodt OptiVantage
DH Power Injector with
OptiBolus (K042744) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The MEDRAD Stellant CT
Injector System is intended
for the specific purpose of
injecting intravenous contrast
media into humans for
diagnostic studies in
computed tomography (CT)
applications. | The MEDRAD Stellant CT
Injector System with ISI
Module is intended for the
specific purpose of injecting
intravenous contrast media
into humans for diagnostic
studies in computed
tomography (CT)
applications. | The OptiVantage with
OptiBolus software feature is
designed to inject a
radiopaque contrast media
into a patient's vascular
system, which enhances
diagnostic images obtained
with computed tomography
(CT). |
| | The P3T CardiacFlow
software accessory computes
individual contrast injection
protocols and scan timing,
based on patient
characteristics, scanner
parameters and contrast
concentration. | | The OptiBolus software
feature is used to enable an
exponential decaying flow
rate injection that will
optimize the contrast usage
and provide an extended
period of uniform
enhancement. |
| | The P3T CardiacFlow
software accessory is | | |
| Feature | Proposed Device:
Stellant CT Injector System
with P3T CardiacFlow
Accessory | Predicate Device:
Stellant CT Injector System
with ISI Accessory (K033881) | Predicate Device:
Mallinckrodt OptiVantage
DH Power Injector with
OptiBolus (K042744) |
| | intended for use in CT
angiography of cardiac
structures, including coronary
arteries, chambers of the
heart, and thoracic and
abdominal aorta during gated
ECG acquisition. | | |
| | The P3T CardiacFlow
software accessory can be
turned on or off by the user
for any given injection The
user will be required to
confirm/change the suggested
protocol before beginning an
injection. | | The OptiBolus software
feature can be turned on or
off by the user for any given
injection protocol. |
| Single or Dual Syringe
System | Dual syringe model | Single and dual syringe
models | Dual syringe model |
| Information Display | Color LCD | Color LCD | Color LCD |
| Programming Keys | Non-dedicated keys –
software determined | Non-dedicated keys –
software determined | Control panel buttons: 8 soft-
keys on touchscreen interface |
| Touch screen | Yes | Yes | Yes |
| Multi-Phase | Up to 6 phases per P3T
CardiacFlow injection | 1 - 6 phases per injection | 6 phases per injection or a
single OptiBolus injection |
4
mentaly
Performance, For life."
:
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Image /page/5/Picture/0 description: The image shows the word "merance" in a large, bold font, oriented vertically. To the right of the word, there is the phrase "For life." in a smaller font. The text is arranged in a way that suggests a brand name or slogan.
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Image /page/6/Picture/0 description: The image shows the word "MEDTRONIC" in large, bold, black letters, oriented vertically. To the right of the word, there is some smaller text that is difficult to read due to the image quality. The text appears to be stacked vertically as well. The overall impression is that of a document or label featuring the Medtronic brand name.
| 5.12 | |
|---|---|
| $A_{wg} = \frac{A_w}{A_g}$ | |
| where: | |
| $A_w =$ area of water surface | |
| $A_g =$ gross surface area | |
| 5.13 | |
| Albedo is the ratio of the amount of radiation reflected by a body to the amount incident on it and is usually expressed as a percentage. Albedo is a measure of the reflectivity of a surface. The albedo is defined as the ratio of the reflected radiation to the incident radiation. It is a dimensionless quantity and ranges from 0 to 1. A perfect reflector has an albedo of 1, while a perfect absorber has an albedo of 0. |
| Feature | Proposed Device:
Stellant CT Injector System
with P3T CardiacFlow
Accessory | Predicate Device:
Stellant CT Injector System
with ISI Accessory (K033881) | Predicate Device:
Mallinckrodt OptiVantage
DH Power Injector with
OptiBolus (K042744) |
|----------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Retract Control | Yes (Automatic) | Yes (Automatic) | Yes, manual |
| Remote Start Switch | Yes | Yes | Yes |
| Pressure Graph | Yes | Yes | No |
| Syringe Sensing | Yes | Yes | Yes |
| Autoload | Yes | Yes | No |
| Auto Dock/Retract/Advance | Yes; user-selectable autodock
and advance; user-selectable
auto-retract | Yes; user-selectable autodock
and advance; user-selectable
auto-retract | No |
| Protocol Lock /
Remote Arming | Yes | Yes | No lock however, user may
arm at head. (May have had
related recall) |
| Check for Air | Yes | Yes | Yes |
| Scan Delay | 1 sec to 300 sec in 1 sec
increments | 1 sec to 300 sec in 1 sec
increments | 1 sec increments starting at 1
sec. Max unknown |
| Test Inject | Yes | Yes | Yes |
| Syringe Heat
Maintainer | Yes | Yes | Yes |
| Flow Profile Display | Yes | Yes | Yes |
| Imaging System
Interface (ISI)
Functionality | Yes | Yes | Yes |
| Protocol specialization | The P3T CardiacFlow software
accessory computes individual | N/A | The OptiBolus software feature
is used to enable an exponential |
| Feature | Proposed Device: | Predicate Device: | Predicate Device: |
| | Stellant CT Injector System | Stellant CT Injector System | Mallinckrodt OptiVantage |
| | with P3T CardiacFlow | with ISI Accessory (K033881) | DH Power Injector with |
| | Accessory | | OptiBolus (K042744) |
| | contrast injection protocols | | decaying flow rate injection that |
| | and scan timing, based on | | will optimize the contrast usage |
| | patient characteristics, scanner | | and provide an extended |
| | parameters and contrast | | period of uniform |
| | concentration. | | enhancement. |
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Image /page/7/Picture/0 description: The image shows the word "mental" in large, bold, black letters, oriented vertically. To the right of the word "mental" is the phrase "Performance, For life.", also oriented vertically. The text is small and difficult to read.
·
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEC 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDRAD, Inc. c/o Ms. Lisa M. Casavant Sr. Regulatory Affairs Specialist One Medrad Drive Indianola, PA 15051
Re: K072886
Stellant CT Injector System with Personalized Patient Protocol Technology (P3T) Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: October 4, 2007 Received: October 9, 2007
Dear Ms. Casavant:
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.
9
Page 2 - Ms. Lisa M. Casavant
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 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,
M. L. Williams
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K072886
Device Name: MEDRAD Stellant CT Injector System with Personalized Patient Protocol Technology (P3T)
Indications for Use:
The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
The Stellant P3T software accessory is intended for use in CT angiography of cardiac structures, including coronary arteries, chambers of the heart, and thoracic and abdominal aorta during gated ECG acquisition.
The Stellant P3T software accessory computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection.
Contraindications:
Stellant P3T is not intended for use in Ungated CT angiography of the Right heart, Pulmonary trunk and Pulmonary Arteries for assessment of thrombo-emboli (dedicated Pulmonary Embolism (PE) studies), for angiography of the head/neck vessels, or for peripheral angiography.
The P3T feature on the Stellant CT Injector is not intended for use on patients with compromised renal or some other contrast adverse related health issue.
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 OF NEEDED)
M. . Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K072886