(168 days)
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 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 provided text describes the MEDRAD Stellant CT Injector System with the Extravasation Detection System (XDS) accessory, which is designed to aid in the detection of intravenous contrast media extravasation during CT applications.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states the intended performance of the XDS accessory without explicitly defining "acceptance criteria" in a separate table. The key performance characteristic mentioned for the XDS accessory is its ability to detect extravasation before 20ml of fluid is extravasated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detect extravasation of intravenous contrast media. | 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. |
| Detect extravasation before a specific volume is accumulated. | "The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated within the sensors' field of view." |
| Provide alerts upon detection. | "Audible and visual alert if an extravasation of up to 20ml is detected under sensor region." |
| Halt the injector system upon extravasation detection. | "Will halt the Stellant injector system in the event of an extravasation event." |
| Does not replace existing healthcare professional duties. | "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." |
| Designed for adults and antecubital injections only. | "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." (This is a contraindication but also defines the scope of validated performance). |
| Compatible with specific Stellant CT Injector models. | "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." (Also a contraindication, implying validated performance within this compatibility). |
| Does not alter injector system's primary functions or performance. | "This accessory does not otherwise alter the injector system's primary functions or performance during a CT procedure." |
| Patient Sensor Technology | Gold-plated antenna shrouded in ferro-plastic absorber covered by a silicone overmold. (This describes the design element for detection, rather than a performance metric, but is relevant to how it meets its detection goal). |
| Material Biocompatibility and Sterilization | Mention of material compositions (e.g., medical grade tape, polyethylene, acrylate adhesive), EtO sterilization, and Limulus Amebocyte Lysate (LAL) test to USP requirements for pyrogen-freeness, indicating compliance with general medical device safety standards for patient contact. |
| Compatibility with existing injector functions (e.g., flow rate) | The comparison table (Table 1) consistently notes that all operational parameters and features of the proposed device related to injection (e.g., flow rate, pressure limit, syringe types, programming) are "Same" as the predicate device, implying that the XDS accessory does not negatively impact these core functionalities. |
Note: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It highlights the design intent and performance claims of the new accessory rather than presenting detailed study results with quantitative metrics against formal acceptance criteria in the way a clinical study report might. It implies that these performance characteristics were verified during the development and testing process for regulatory submission.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies supporting the XDS accessory. 510(k) summaries often focus on design and functional verification rather than detailed clinical trial data, especially for accessories that don't directly modify the primary therapeutic or diagnostic output of the main device. The information indicates that the XDS accessory "provides a supplemental monitoring function" and "does not impose additional risk to the patient," suggesting that extensive clinical trials might not have been deemed necessary for this type of device accessory to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used or their qualifications to establish ground truth for any test set. Given the nature of extravasation detection (a physical event during an injection), the "ground truth" during testing would likely be based on direct observation of fluid leakage, either in vitro models or potentially controlled in vivo animal studies, rather than expert interpretation of images or clinical outcomes from human subjects.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set. This type of detail is usually found in clinical trial protocols where expert consensus is needed to define an endpoint or ground truth, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The XDS accessory is described as a supplemental monitoring function and does not replace human diligence. Therefore, a study comparing human readers with and without AI assistance (which would be the purpose of an MRMC study if the XDS were an AI diagnostic tool) is not applicable or described in this submission. Its function is to alert, not to interpret images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
While not explicitly called a "standalone study", the core functional description of the XDS accessory implies a standalone performance objective: "The XDS accessory is designed to detect and notify the user before 20ml of fluid is extravasated... Will halt the Stellant injector system in the event of an extravasation event." This suggests that the detection mechanism operates independently to identify extravasation and trigger an alert/halt, regardless of human interaction. The device's ability to detect extravasation up to 20ml and then alert/halt the injector system is its standalone performance claim. However, no specific study data or methodology for proving this standalone performance is detailed in the summary.
7. The Type of Ground Truth Used
Given the function of the device, the ground truth for extravasation detection would most likely be direct physical observation of fluid extravasation, either in in-vitro models designed to simulate antecubital injections or potentially in-vivo animal models. The document does not specify the exact method for establishing ground truth, but for a physical detection system, it wouldn't typically involve expert consensus on images or pathology as it would for a diagnostic imaging AI. It's about physically sensing the presence of extravasated contrast.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. The XDS accessory, based on its description (gold-plated antenna, ferro-plastic absorber), appears to be leveraging sensor technology to detect changes related to extravasation rather than being a machine learning or AI-driven system that would traditionally require a "training set" in the context of image analysis or algorithm development. Therefore, the concept of a training set as typically understood for AI/ML devices might not be directly applicable, or if any calibration/parameterization was done, it's not detailed.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a "training set" or AI/ML components for which a training set ground truth would be established, this information is not provided in the document.
Summary of what's provided for studies:
The 510(k) summary primarily focuses on describing the device, its intended use, contraindications, and demonstrating substantial equivalence to a predicate device by comparing features and operational parameters. It states the functional goal of the XDS accessory (detecting extravasation before 20ml and halting the injector) but does not include detailed information about specific studies, sample sizes, expert involvement, or adjudication methods that would typically be found in a clinical study report for an AI/ML device or a device requiring extensive clinical validation. The nature of the device as a physical sensor-based detection system, rather than an image interpretation system, likely means the validation approach focused on engineering performance, reliability, and safety in simulated or bench environments to demonstrate its functional claims.
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510(K) SUMMARY
| OFFICIAL CONTACT: | Troy A. JackSr. Regulatory Affairs SpecialistMEDRAD, Inc.One MEDRAD DriveIndianola, 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 SystemInterface 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.
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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:
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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 ISIAccessory (K033881) | Proposed Device:Stellant CT Injector System withXDS Accessory | |
|---|---|---|---|
| Intended Use | The MEDRAD Stellant CT InjectorSystem with ISI Module is intendedfor the specific purpose of injectingintravenous contrast media intohumans for diagnostic studies incomputed tomography (CT)applications. | The MEDRAD Stellant CT InjectorSystem with ISI Module is intendedfor the specific purpose of injectingintravenous contrast media intohumans for diagnostic studies incomputed tomography (CT)applications.The XDS accessory is designedspecifically to aid in the detection ofleakage of intravenous contrastmedia from the injection site intothe surrounding tissue duringdiagnostic studies in computedtomography (CT) applications. | |
| Single or Dual SyringeSystem | Single and dual syringe models | Same | |
| Information Display | Color LCD | Same | |
| Programming Keys | Non-dedicated keys - softwaredetermined | Same | |
| Touch screen | Yes | Same | |
| Multi-Phase | 1 - 6 phases per injection | Same | |
| Arming Modes | Single | Same | |
| Protocol StorageCapability | 32 protocols | Same | |
| Hold Capability | 20 minutes max. | Same | |
| Scan Delay | 1 – 300 seconds | Same | |
| Safety Stop Mechanism | Multi-layered software stops withbackup monitoring | Same | |
| Syringe System | Single syringe model: one 200 mlsyringeDual syringe model: two 200 mlsyringes | Same | |
| Programmed Volume | 1 to 200 ml | Same | |
| Volume RemainingReadout | LED on injector head; graphical andnumeric on LCD | Same | |
| Fill Rate | Variable up to 10 mL/sec | Same | |
| Flow Rate | 0.1mL/sec to 10.0 mL/sec | Same | |
| ProgrammablePressure Limit | 325 PSI default; user settable 50 to 325PSI | Same | |
| Pause | Programmable - 1 sec to 900 sec in 1sec 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 ISIAccessory (K033881) | Proposed Device:Stellant CT Injector System withXDS Accessory | |
| Pressure Graph | Yes | Same | |
| Syringe Sensing | Yes | Same | |
| Autoload | Yes | Same | |
| AutoDock/Retract/Advance | Yes; user-selectable autodock andadvance; user-selectable auto-retract | Same | |
| Protocol Lock / RemoteArming | 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 HeatMaintainer | Yes | Same | |
| Flow Profile Display | Yes | Same | |
| Imaging SystemInterface Functionality | Yes | Same | |
| Patient Sensor | N/A | Gold-plated antenna shrouded inferro-plastic absorber covered by asilicone overmold | |
| Extravasation DetectorPerformance | N/A | Audible and visual alert if anextravasation of up to 20ml isdetected under sensor region. Willhalt the Stellant injector system inthe event of an extravasation event. | |
| Feature | Predicate Device:Stellant CT Injector System(K033881) | Proposed Device:Stellant CT Injector Systemwith XDS Accessory | |
| Administration Set Packaging | Tyvek lid covering polystyrenetray | Same | |
| Sterilization | EtO sterilization | Same | |
| Method of determiningPyrogen-Freeness | Limulus Amebocyte Lysate test toUSP requirements | Same | |
| Luer Fittings | ISO 594-1 & ISO 594-2 compliantdesign | 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 (noalignment necessary) | Same | |
| Syringe sensing feature | Grooves at bottom of barrel to beoptically identified | Same | |
| Connector TubingComponents: | |||
| 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/SalineContainer Spike | ABS | Same | |
| Priming Tube | Low density polyethylene | Same | |
| XDS Disposable Components: | |||
| Sensor Interface Disposable(SID) | N/A | Medical Grade Tape(Polyester) with AcrylateAdhesive | |
| SID Packaging | N/A | Polyester + Polyethylene withPaper Backing | |
| SID Sterilization | N/A | EtO sterilization | |
| Cable Management Tape (QuickStrips) | N/A | Medical Grade Tape(Polyethylene) with AcrylateAdhesive | |
| Cable Management Tape(Quick Strips) Packaging | N/A | Polyester + Polyethylene withPaper Backing | |
| Cable Management Tape(Quick Strips) Sterilization | N/A | EtO sterilization |
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and the count
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Table 2 - COMPARISON OF STELLANT CT INJECTOR SYSTEM AND XDS ACCESSORY DISPOSABLES
...
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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.
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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
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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
§ 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.