(65 days)
The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.
The Medrad Spectris Solaris EP MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially undein a manner similar to the predicate device. The Spectris Solaris EP MR Injector is comprised of the same two main components as the predicate device - Injector Head/Stand (HSU) and Display Control Unit (DCU).
The provided text is a 510(k) summary for the Medrad Spectris Solaris EP MR Injector System, which is a device intended for delivering contrast media during MR applications. This document does not contain information on acceptance criteria or a study proving that the device meets specific acceptance criteria related to its performance.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria as might be seen for novel technologies or higher-risk devices.
Here's what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided document. The submission focuses on comparing features and operational parameters to a predicate device, not on quantitative performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not available. No test set or data provenance is mentioned as this is a 510(k) submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available. There is no mention of a test set or ground truth established by experts.
4. Adjudication method for the test set:
This information is not available. No test set or adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/available. The device is an injector, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/available. The device is an injector and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/available. No ground truth is mentioned.
8. The sample size for the training set:
This information is not applicable/available. No training set is mentioned.
9. How the ground truth for the training set was established:
This information is not applicable/available. No training set or ground truth is mentioned.
Summary of what the document does provide regarding device comparison:
The document outlines the similarities and differences between the new device (Medrad Spectris Solaris EP MR Injector System) and its predicate device (Medrad Spectris Solaris MR Injector System K033247). The core argument for substantial equivalence relies on the "same intended use, similar operational parameters, similar labeling and is essentially unde in a manner similar to the predicate device."
Detailed comparison tables show that for most features, the new device is "Same" as the predicate device. The only feature with a slight difference mentioned appears to be the "Flow Rate Injector" where the predicate device specifies two ranges:
- 1 ml/sec to 10 ml/sec +/- (10% +/- 0.02 ml/sec)
- 0.01 ml/sec to 0.99 ml/sec +/- (10% + 0.005 ml/sec)
The new device simply states "Same" for this feature, implying it meets these specifications.
Another minor difference is in the "Syringe System" under "Disposable System," where the new device lists "2 total, 1- 115 ml syringe and 1- 65 ml syringe, 2 - 65 ml syringes" while the predicate lists "2 total, 1- 115 ml syringe and 1- 65 ml syringe." This seems to indicate an additional option for syringe configurations.
The FDA's decision to grant 510(k) clearance is based on the determination that the device is "substantially equivalent" to the predicate device, not necessarily on a detailed study demonstrating performance against specific acceptance criteria in the way a clinical trial for a new drug or novel medical algorithm would.
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DEC 1 0 2004
510(k) Summary
| OFFICIAL CONTACT: | John M KisteRegulatory Affairs SpecialistMedrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 ext. 3444 |
|---|---|
| CLASSIFICATION NAME: | Injector with Syringe, Angiographic |
| COMMON NAME(S): | Powered Injector with Syringe |
| PROPRIETARY NAME: | Medrad Spectris Solaris EP MR Injector System |
| PREDICATE DEVICE: | Medrad Spectris Solaris MR Injector System (3TCompatible) (K033247) |
| INTENDED USE: | The Spectris Solaris EP MR Injection System is asyringe-based fluid delivery system indicated fordelivery of contrast media during MR applications.It is intended to be used for the specific purpose ofinjecting intravenous MR contrast media andcommon flushing solutions into the humanvascular system for diagnostic studies in magneticresonance imaging (MRI) procedures. Only trainedhealthcare professionals are intended to operatethis device. |
DEVICE DESCRIPTION AND COMPARISON TO PREDICATE:
The Medrad Spectris Solaris EP MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially undein a manner similar to the predicate device.
The Spectris Solaris EP MR Injector is comprised of the same two main components as the predicate device - Injector Head/Stand (HSU) and Display Control Unit (DCU). Differences between the predicate device and the new Spectris Solaris EP MR (DCO) are detailed in the table below. The following Comparison Matrix identifies the similarities and differences between the new device and the predicate device.
| Feature:Injector System | Medrad Spectris Solaris MR Injector(3T Compatible)(K033247)Predicate | Medrad Spectris Solaris EP MRInjector |
|---|---|---|
| Flow Rate Injector | 1 ml/sec to 10 ml/sec$+/-(10%+/-0.02 ml/sec)$ | Same |
| 0.01ml/sec to 0.99ml/sec$+/-(10%+0.005ml/sec)$ |
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| Feature:Injector System | Medrad Spectris Solaris MR Injector(3T Compatible)(K033247)Predicate | Medrad Spectris Solaris EP MRInjector |
|---|---|---|
| Fractional volumes | Yes | Same |
| Remote InformationDisplay | Color Touch screen | Same |
| Multi-Phase | 6 | Same |
| Protocol StorageCapability | Yes; 3 step procedure32 protocols | Same |
| Hold Capability | Yes | Same |
| Safety StopMechanism | Yes | Same |
| Syringe System | 2 total, 1- 115 ml syringe and 1- 65 mlsyringe | Same |
| Air Detection Device | User observable | Same |
| Syringe Sensing | Yes | Same |
| Volume RemainingReadout | Graduation on syringe; LCD onProgram Panel | Same |
| Programmed Volume | Yes, 1 to 63 ml and 1-115 ml | Same |
| Fill Rate | Configurable up to a maximum of 10ml/sec | Same |
| Flow Rate | Variable | Same |
| KVO | Yes; 0.25 ml, time adjustable. Defaultsat every 30 sec. | Same |
| Pressure Limit | 311 PSI for Syringe A310 PSI for Syringe B | Same |
| Start/Stop switch | Yes, Located at injector head or atdisplay unit. | Same |
| Communication | Fiber Optic | Same |
| System Compatibility | 0.2 - 3 T | Same |
:
| Feature: | ||
|---|---|---|
| Disposable System | ||
| Syringe System | 2 total, 1- 115 ml syringe and 1-65 ml syringe, 2 - 65 ml syringes | |
| Intended Use | Saline/Contrast delivery | Same |
| Barrel Material Composition | PET | Same |
| Barrel length | 4.5" | Same |
| Barrel OD | 1.565" | Same |
| Barrel ID | 1.415 | Same |
| Plunger Material Composition | Polycarbonate | Same |
| Barrel Flange | Quik-Fit Design | Same |
| Packaging | Polystyrene tray with Tyvek Lid | Same |
| Sterilization | Ethylene Oxide | Same |
| Medrad -T connector | ||
| T-connector | Polycarbonate | Same |
| Tubing | PVC | Same |
| Luer Fitting | Polycarbonate | Same |
| Length | 96" | Same |
| Tubing ID | 0.075" | Same |
| Maximum Pressure | 350 PSI | Same |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Medrad, Inc. c/o Mr. John M. Kiste Regulatory Affairs Specialist One Medrad Drive Indianola, PA 15051
K042784 Re:
Medrad Spectris Solaris MR Injector System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: November 9, 2004 Received: November 10, 2004
Dear Mr. Krite:
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. John M. Kiste
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Singerely yours.
Prem D. Zuckerman, M.D.
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:
Device Name: Medrad Spectris Solaris EP MR Injector
Indications for Use:
The Spectris Solaris EP MR Injection System is a syringe-based fluid delivery system indicated for delivery of contrast media during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and common flushing solutions into the nysessions intravellous MIC connals media and common resonance imaging (MRI) procedures. Only trained healthcare professionals are intended to operate this device.
Prescription Use x (Per 21 CFR 801 Subpart D)
AND/ OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE ON THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K042784 |
Page 1 of 1
§ 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.