(29 days)
The Spectris Solaris 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 MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device.
A label will be affixed to the 3.0 Tesla-compatible injector system stating that the injector should be placed at a minimum of 4 ft. from the magnet bore when used with magnetic resonance imaging scanners having a field strength greater than 2.0 Tesla. The user's manual has also been updated to include this warning.
The Spectris Solaris MR Injector (3T Compatible) 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 MR Injector System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. The changes described are primarily related to increasing the system's compatibility with higher magnetic field strengths (from 2.0 T to 3.0 T).
Therefore, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" as might be expected for a new AI/software-based medical device with performance metrics (like sensitivity, specificity, or accuracy) are not present in this document. Instead, the "acceptance criteria" are implied by showing the new device maintains similar operational parameters, similar labeling, and the same intended use as the predicate device, with the key difference being the expanded 3T compatibility.
Here's an attempt to answer your questions based on the available information, noting that many fields will be "Not Applicable" or "Not Provided" given the nature of a 510(k) for a hardware modification:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| - Maintain existing flow rate range (0.01 - 10 ml/s) | - Same (0.01 - 10 ml/s) |
| - Maintain fractional volumes capability | - Same (Yes) |
| - Maintain remote information display (color touch screen) | - Same (Color Touch screen) |
| - Maintain multi-phase capability (6 phases) | - Same (6) |
| - Maintain protocol storage capability (32 protocols, 3 steps) | - Same (Yes: 3 step procedure, 32 protocols) |
| - Maintain hold capability | - Same (Yes) |
| - Maintain safety stop mechanism | - Same (Yes) |
| - Maintain syringe system (2 total: 1-115ml, 1-65ml) | - Same (2 total: 1-115ml syringe and 1-65ml syringe) |
| - Maintain air detection (user observable) | - Same (User observable) |
| - Maintain syringe sensing | - Same (Yes) |
| - Maintain volume remaining readout | - Same (Graduation on syringe; LCD on Program Panel) |
| - Maintain programmed volume (1-63ml and 1-115ml) | - Same (Yes, 1 to 63 ml and 1-115 ml) |
| - Maintain fill rate (up to 10 ml/sec) | - Same (Configurable up to a maximum of 10 ml/sec) |
| - Maintain variable flow rate | - Same (Variable) |
| - Maintain KVO (0.25 ml, time adjustable, every 30 sec default) | - Same (Yes: 0.25 ml, time adjustable. Defaults at every 30 sec.) |
| - Maintain pressure limit (325 PSI for injector) | - Same (325 PSI) |
| - Maintain start/stop switch functionality | - Same (Yes, Located at injector head or at display unit.) |
| - Maintain communication method (Fiber Optic) | - Same (Fiber Optic) |
| Increased System Compatibility: | |
| - Operate safely and effectively with 3.0 Tesla MR scanners | - Achieved: System Compatibility expanded to 0.2 - 3 T (from 0.2 - 2 T) |
| (Implied: Electromagnetic compatibility, minimal interference) | (Labeling update for 4 ft. placement from magnet bore) |
| Disposable System Equivalence: | |
| - Syringe system (2 total: 1-115ml, 1-65ml or 2-65ml) | - Same (2 total, 1- 115 ml syringe and 1- 65 ml syringe, 2 - 65 ml syringes) |
| - Intended use (saline/contrast delivery) | - Same (Saline/Contrast delivery) |
| - Barrel material/dimensions (PET, 4.5" length, 1.565" OD, 1.415 ID) | - Same (PET, 4.5", 1.565", 1.415) |
| - Plunger material (Polycarbonate) | - Same (Polycarbonate) |
| - Barrel flange (Quik-Fit Design) | - Same (Quik-Fit Design) |
| - Packaging/Sterilization (Polystyrene tray with Tyvek Lid, EtO) | - Same (Polystyrene tray with Tyvek Lid, Ethylene Oxide) |
| - T-connector material/tubing (Polycarbonate, PVC) | - Same (Polycarbonate, PVC) |
| - Luer Fitting (Polycarbonate) | - Same (Polycarbonate) |
| - Tubing length/ID (96", 0.075") | - Same (96", 0.075") |
| - Maximum Pressure (350 PSI for T-connector) | - Same (350 PSI) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided. This type of detail is not typically included in a 510(k) summary for a hardware modification of this nature. The "study" here is primarily an engineering assessment of compatibility and equivalence to the predicate device.
- The comparison matrix explicitly states "Same" for most features, indicating that those parts of the system are unchanged and therefore assumed to perform identically to the previously cleared predicate. For the 3T compatibility, specific testing (e.g., electromagnetic compatibility, performance under higher magnetic fields) would have been performed, but the details (like sample size of tests or data provenance) are not summarized here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided. "Ground truth" in the context of diagnostic accuracy is not relevant here. This is a functional/safety equivalence submission for an injector system. The "experts" involved would be Medrad's own engineers and potentially external testing labs for aspects like EMC, but their qualifications and numbers are not part of the public 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. Adjudication methods are typically for evaluating subjective interpretations, often in diagnostic imaging. This device is an injector, so such methods would not apply.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI or diagnostic imaging device. It's a contrast media injector.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this device, "ground truth" would relate to engineering specifications and performance metrics of the injector system (e.g., accuracy of flow rate, pressure limits, structural integrity, electromagnetic compatibility). These are objective measurements against established engineering standards and specifications, not subjective medical diagnoses.
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. This device does not use a "training set."
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NOV - 5 2003
510(k) Summary
| OFFICIAL CONTACT: | Troy A. JackRegulatory Affairs AnalystMedrad, 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 Spectris Solaris MR Injector System |
| PREDICATE DEVICE: | Medrad Spectris Solaris MR Injector System(K012950) |
| INTENDED USE: | The Spectris Solaris 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 UNMODIFIED PREDICATE:
The Medrad Spectris Solaris MR Injection System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device.
A label will be affixed to the 3.0 Tesla-compatible injector system stating that the injector should be placed at a minimum of 4 ft. from the magnet bore when used with magnetic resonance imaging scanners having a field strength greater than 2.0 Tesla. The user's manual has also been updated to include this warning.
The Spectris Solaris MR Injector (3T Compatible) 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 MR Injector are detailed in the table below. The following Comparison Matrix identifies the similarities and differences between the new device and the predicate device.
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| Feature:Iniector System | Medrad Spectris Solaris MR Injector(K012950)Predicate | Medrad Spectris Solaris MR Injector |
|---|---|---|
| Flow Rate Injector | 0.01 - 10 ml/s in 0.01 incrementsbetween .01 and 3.1 ml/s, 0.1 ml/sincrements between 3.1 and 10 mls. | Same |
| 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 | 325 PSI | Same |
| Start/Stop switch | Yes, Located at injector head or atdisplay unit. | Same |
| Communication | Fiber Optic | Same |
| System Compatibility | 0.2 - 2 T | 0.2 - 3 T |
| 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
NOV - 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medrad, Inc. c/o Mr. Troy A. Jack Regulatory Affairs Analyst One Medrad Drive Indianola, PA 15051
Re: K033247
Medrad Spectris Solaris MR Injector Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: October 10, 2003 Received: October 14, 2003
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. Iisting 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 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 (301) 594-4648. 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
Sincerely yours,
Thosa Diaz 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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Intended Use
There has been no change to the indications for use as a result of the proposed modifications described in this submission.
Indications for Use Statement
510(k) Number:
16333241
Medrad Spectris Solaris MR Injector Device Name:
Indications for Use:
The Spectris Solaris 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number
1/4/13
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Prescription Use X EDMAfMDZ 11/4/03
(Per 21 CFR 801.109)
§ 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.