(56 days)
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No
The summary describes a fluid injection system with an interface, and there is no mention of AI, ML, or related concepts.
No
The device is used for injecting contrast media for diagnostic studies in Magnetic Resonance Imaging, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used to inject contrast media for "diagnostic studies in Magnetic Resonance Imaging," indicating its role in facilitating diagnostic procedures.
No
The device description explicitly states it is a "syringe-based fluid delivery system," which is a hardware component. The "Communicator™ Option" appears to be an interface, but the core device is a physical injector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for injecting intravenous contrast media during Magnetic Resonance Imaging (MRI) applications and for intravenous access for diagnostic studies in MRI. This describes a device used in vivo (within a living organism) to facilitate an imaging procedure.
- 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. The Spectris MR Injection System does not perform any tests on bodily samples.
- Device Description: The description confirms it's a "syringe-based fluid delivery system," which aligns with its role in injecting substances into the body.
Therefore, the Spectris MR Injection System is a medical device used in conjunction with an imaging modality (MRI), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spectris MR Injection System with Communicator ™ is a syringe-based fluid delivery System intended to be used for the specific purpose of injecting intravenous contrast media during Magnetic Resonance Imaging applications. It is intended to provide an imaging system interface for diagnostic studies in Magnetic Contast Imaging . The Communicator connection provides an imaging system interface . Medically trained healthcare professionals are intended to operate this device.
Product codes
74 DXT
Device Description
Medrad Spectris MR Injector with Communicator™ Option
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Medically trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/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 swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
AUG 2 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lorraine R. Fredes Sr. Regulatory Affairs Coordinator Medrad. Incorporated One Medical Drive Indianola. PA 15051
Re: K011991
Medrad Spectris MR Injector with Communicator™ Option Regulation Number: 870.1650 Regulatory Class: II (two) Product Code: 74 DXT Dated: July 31, 2001 Received: July 31, 2001
Dear Ms. Fredes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Lorraine R. Fredes
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Oella Tella
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K011991/S/ |
|---|---|
| ---------------- | ------------ |
Medrad Spectris MR Injector with Communicator TM Option Device Name:
Indications for Use:
The Spectris MR Injection System with Communicator ™ is a syringe-based fluid delivery The Spectris MK Injection Of contrast media during Magnetic Resonance Imaging System indications. It is intended to be used for the specific purpose of injecting intravenous apprications. It is michiled to be access for diagnostic studies in Magnetic Contast Imaging . The Communicator connection provides an imaging system interface Resoliation injuging . The Communically trained healthcare professionals are intended to operate this device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K011991 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
- Medrad, Inc. Special 510(k) Premarket Submission Medrad Spectris MR Injectors with Communicator TM . Confidential .
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