(29 days)
Not Found
No
The summary describes a fluid delivery system for contrast media injection during MRI and makes no mention of AI or ML capabilities.
No
The device delivers contrast media for diagnostic studies in MRI procedures, which is a diagnostic function, not a therapeutic one.
No
Explanation: The device is an injection system used to deliver contrast media for diagnostic studies, but it is not a diagnostic device itself. It facilitates the diagnostic imaging process rather than performing the diagnosis.
No
The device description explicitly states it is comprised of two main hardware components: an Injector Head/Stand (HSU) and a Display Control Unit (DCU). This indicates it is a hardware device with likely integrated software, not a software-only medical 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.
- Device Function: The Spectris Solaris MR Injection System is a device used to deliver contrast media directly into the human vascular system during an MRI procedure. It is an in vivo (within the living body) device, not an in vitro (outside the living body) device.
- Intended Use: The intended use clearly states it's for "injecting intravenous MR contrast media and common flushing solutions into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures." This is a direct intervention on the patient, not a test performed on a sample.
Therefore, the Spectris Solaris MR Injection System is a medical device used in conjunction with an imaging modality (MRI) for diagnostic purposes, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI)
Anatomical Site
human vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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
NOV - 5 2003
510(k) Summary
| OFFICIAL CONTACT: | Troy A. Jack
Regulatory Affairs Analyst
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 Spectris Solaris MR Injector System |
| PREDICATE DEVICE: | Medrad Spectris Solaris MR Injector System
(K012950) |
| INTENDED 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. |
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.
1
| 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 increments
between .01 and 3.1 ml/s, 0.1 ml/s
increments between 3.1 and 10 mls. | Same |
| Fractional volumes | Yes | Same |
| Remote Information
Display | Color Touch screen | Same |
| Multi-Phase | 6 | Same |
| Protocol Storage
Capability | Yes: 3 step procedure
32 protocols | Same |
| Hold Capability | Yes | Same |
| Safety Stop
Mechanism | Yes | Same |
| Syringe System | 2 total, 1- 115 ml syringe and 1- 65 ml
syringe | Same |
| Air Detection Device | User observable | Same |
| Syringe Sensing | Yes | Same |
| Volume Remaining
Readout | Graduation on syringe; LCD on
Program Panel | Same |
| Programmed Volume | Yes, 1 to 63 ml and 1-115 ml | Same |
| Fill Rate | Configurable up to a maximum of 10
ml/sec | Same |
| Flow Rate | Variable | Same |
| KVO | Yes: 0.25 ml, time adjustable. Defaults
at every 30 sec. | Same |
| Pressure Limit | 325 PSI | Same |
| Start/Stop switch | Yes, Located at injector head or at
display 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 |
2
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.
3
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
4
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)