(168 days)
Not Found
No
The summary describes a fluid delivery system and an extravasation detection accessory based on physical detection, with no mention of AI/ML terms, image processing for analysis, or performance studies typical of AI/ML devices.
No
The device is used to inject contrast media for diagnostic studies in CT applications, not to treat a disease or medical condition.
No
The device is an injector system designed to deliver contrast media for diagnostic studies and to detect extravasation, but it does not directly perform a diagnostic function itself. The diagnostic function is performed by the CT scanner.
No
The device description explicitly states it is a "syringe-based fluid delivery system" and an "accessory" designed to aid in detection, indicating hardware components are involved in the function of the device.
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 provide information for diagnosis, monitoring, or screening.
- Device Function: The MEDRAD Stellant CT Injector System and XDS accessory are used to inject contrast media into the body and detect extravasation during a CT scan. They are involved in the delivery and monitoring of a substance within the body, not the analysis of a sample taken from the body.
- Intended Use: The intended use clearly states the purpose is for injecting contrast media for diagnostic studies in CT applications and aiding in the detection of extravasation. This is an in-vivo (within the living body) procedure.
Therefore, the function and intended use of this device fall outside the scope of in vitro diagnostics.
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 MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications.
Contraindications: The XDS System is not intended for portable use or for use in an MR environment. The XDS System is designed for use on adults with antecubital injections only. The system is not validated for use on the back of the hand or in pediatrics.
The Control Room Module / Stellant Interface signal output is not intended to be used with any equipment other than with MEDRAD Stellant CT Injectors models SX and DX.
Product codes (comma separated list FDA assigned to the subject device)
IZQ
Device Description
The XDS Accessory may be added to the MEDRAD Stellant CT Injector System as an optional accessory. The injector system, when used with the XDS accessory, maintains the same intended use, same operational parameters, same labeling (with the addition of an XDS-specific operations manual). This device is also used in the same manner as the predicate device.
The Stellant CT Injector System with XDS accessory 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. The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications. The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated within the sensors' field of view.
The XDS accessory does not replace or change the existing duties of the healthcare professionals performing a CT scan. This accessory provides a supplemental monitoring function to normal extravasation diligence and therefore does not impose additional risk to the patient. The device will exclusively interface with the Stellant CT Injector System, halting it in the event of an extravasation. This accessory does not otherwise alter the injector system's primary functions or performance during a CT procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare professionals performing a CT scan.
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)
Not Found
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.
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
510(K) SUMMARY
| OFFICIAL CONTACT: | Troy A. Jack
Sr. Regulatory Affairs Specialist
MEDRAD, Inc.
One MEDRAD Drive
Indianola, PA 15051
(412) 767-2400 ext. 3305 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic |
| COMMON NAME(S): | Powered Injector with Syringe |
| PROPRIETARY NAME: | MEDRAD Stellant CT Injector System with XDS Accessory |
| PREDICATE DEVICE: | MEDRAD Stellant CT Injector System with Imaging System
Interface Module (K033881) |
MAR 27 2007INTENDED 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 MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications.
CONTRAINDICATIONS: The XDS System is not intended for portable use or for use in an MR environment. The XDS System is designed for use on adults in antecubital injections only. The system is not validated for use on the back of the hand or in pediatrics.
The Control Room Module/Stellant Interface signal output is not intended to be used with any equipment other than with Medrad Stellant CT Injector models Sx and Dx.
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE: The XDS Accessory may be added to the MEDRAD Stellant CT Injector System as an optional accessory. The injector system, when used with the XDS accessory, maintains the same intended use, same operational parameters, same labeling (with the addition of an XDS-specific operations manual). This device is also used in the same manner as the predicate device.
The Stellant CT Injector System with XDS accessory 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. The MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications. The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated within the sensors' field of view.
1
The XDS accessory does not replace or change the existing duties of the healthcare professionals performing a CT scan. This accessory provides a supplemental monitoring function to normal extravasation diligence and therefore does not impose additional risk to the patient. The device will exclusively interface with the Stellant CT Injector System, halting it in the event of an extravasation. This accessory does not otherwise alter the injector system's primary functions or performance during a CT procedure. Differences between the predicate device and the Stellant CT Injector System with XDS functionality are detailed in the Tables 1 and 2:
2
Table 1 - COMPARISON OF STELLANT CT INJECTOR SYSTEM w/ XDS ACCESSORY and STELLANT CT INJECTOR SYSTEM w/ ISI
...
| Feature | Predicate Device:
Stellant CT Injector System with ISI
Accessory (K033881) | Proposed Device:
Stellant CT Injector System with
XDS Accessory | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use | 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 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 XDS accessory is designed
specifically to aid in the detection of
leakage of intravenous contrast
media from the injection site into
the surrounding tissue during
diagnostic studies in computed
tomography (CT) applications. | |
| | Single or Dual Syringe
System | Single and dual syringe models | Same |
| | Information Display | Color LCD | Same |
| | Programming Keys | Non-dedicated keys - software
determined | Same |
| | Touch screen | Yes | Same |
| | Multi-Phase | 1 - 6 phases per injection | Same |
| | Arming Modes | Single | Same |
| Protocol Storage
Capability | 32 protocols | Same | |
| Hold Capability | 20 minutes max. | Same | |
| Scan Delay | 1 – 300 seconds | Same | |
| Safety Stop Mechanism | Multi-layered software stops with
backup monitoring | Same | |
| Syringe System | Single syringe model: one 200 ml
syringe
Dual syringe model: two 200 ml
syringes | Same | |
| | Programmed Volume | 1 to 200 ml | Same |
| | Volume Remaining
Readout | LED on injector head; graphical and
numeric on LCD | Same |
| | Fill Rate | Variable up to 10 mL/sec | Same |
| Flow Rate | 0.1mL/sec to 10.0 mL/sec | Same | |
| Programmable
Pressure Limit | 325 PSI default; user settable 50 to 325
PSI | Same | |
| Pause | Programmable - 1 sec to 900 sec in 1
sec increments | Same | |
| Autofill | Fill rate 4 mL/sec | Same | |
| Retract Control | Yes (Automatic) | Same | |
| Remote Start Switch | Yes | Same | |
| Feature | Predicate Device:
Stellant CT Injector System with ISI
Accessory (K033881) | Proposed Device:
Stellant CT Injector System with
XDS Accessory | |
| Pressure Graph | Yes | Same | |
| Syringe Sensing | Yes | Same | |
| Autoload | Yes | Same | |
| Auto
Dock/Retract/Advance | Yes; user-selectable autodock and
advance; user-selectable auto-retract | Same | |
| Protocol Lock / Remote
Arming | Yes | Same | |
| Remote Check for Air
(from Head) | Yes | Same | |
| Scan Delay | 1 sec to 300 sec in 1 sec increments | Same | |
| Store/Recall | 32 protocols | Same | |
| Test Inject | Yes | Same | |
| Syringe Heat
Maintainer | Yes | Same | |
| Flow Profile Display | Yes | Same | |
| Imaging System
Interface Functionality | Yes | Same | |
| Patient Sensor | N/A | Gold-plated antenna shrouded in
ferro-plastic absorber covered by a
silicone overmold | |
| Extravasation Detector
Performance | N/A | Audible and visual alert if an
extravasation of up to 20ml is
detected under sensor region. Will
halt the Stellant injector system in
the event of an extravasation event. | |
| Feature | Predicate Device:
Stellant CT Injector System
(K033881) | Proposed Device:
Stellant CT Injector System
with XDS Accessory | |
| Administration Set Packaging | Tyvek lid covering polystyrene
tray | Same | |
| Sterilization | EtO sterilization | Same | |
| Method of determining
Pyrogen-Freeness | Limulus Amebocyte Lysate test to
USP requirements | Same | |
| Luer Fittings | ISO 594-1 & ISO 594-2 compliant
design | Same | |
| Syringe: | | | |
| Barrel Material Composition | Polyethylene Terephthalate | Same | |
| Barrel Length | 7.504" | Same | |
| Barrel OD | 2.002" | Same | |
| Barrel ID | 1.844" | Same | |
| Plunger Material Composition | Polycarbonate | Same | |
| Plunger Cover | Polyisoprene | Same | |
| Plunger Silicone Coating | Polydimethylsiloxane (Silicone) | Same | |
| Barrel Flange | Easy-engage design for non-
rotational orientation (no
alignment necessary) | Same | |
| Syringe sensing feature | Grooves at bottom of barrel to be
optically identified | Same | |
| Connector Tubing
Components: | | | |
| Maximum Pressure | 400 psi | Same | |
| Tube Material | Medical grade PVC | Same | |
| Tube Length | 60" | Same | |
| Bonding Agent | Cyclohexanone | Same | |
| T-connector | Medical grade polycarbonate | Same | |
| Contrast Media/Saline
Container Spike | ABS | Same | |
| Priming Tube | Low density polyethylene | Same | |
| XDS Disposable Components: | | | |
| Sensor Interface Disposable
(SID) | N/A | Medical Grade Tape
(Polyester) with Acrylate
Adhesive | |
| SID Packaging | N/A | Polyester + Polyethylene with
Paper Backing | |
| SID Sterilization | N/A | EtO sterilization | |
| Cable Management Tape (Quick
Strips) | N/A | Medical Grade Tape
(Polyethylene) with Acrylate
Adhesive | |
| Cable Management Tape
(Quick Strips) Packaging | N/A | Polyester + Polyethylene with
Paper Backing | |
| Cable Management Tape
(Quick Strips) Sterilization | N/A | EtO sterilization | |
3
and the count
4
Table 2 - COMPARISON OF STELLANT CT INJECTOR SYSTEM AND XDS ACCESSORY DISPOSABLES
...
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2007
Medrad, Inc. c/o Mr. Troy A. Jack Senior Regulatory Affairs Specialist One Medrad Drive Indianola, PA 15051
Re: K063090
Trade/Device Name: Stellant CT Injector System with Extravasation Detector Accessory Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: IZQ Dated: March 21, 2007 Received: March 23, 2007
Dear Mr. Jack:
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.
6
Page 2 - Mr. Troy A. Jack
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.
Sincerely yours,
Blommor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K063090
Device Name: MEDRAD Stellant CT Injector System with Extravasation Detection Accessory
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 MEDRAD Extravasation Detection System (XDS) accessory is designed to aid in the detection of intravenous contrast media from the injection site into the surrounding tissue during diagnostic studies in computed tomography (CT) applications.
Contraindications: The XDS System is not intended for portable use or for use in an MR environment. The XDS System is designed for use on adults with antecubital injections only. The system is not validated for use on the back of the hand or in pediatrics.
The Control Room Module / Stellant Interface signal output is not intended to be used with any equipment other than with MEDRAD Stellant CT Injectors models SX and DX.
Prescription Use (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)
B
concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K063090