(30 days)
The Spectris Solaris MR Injection System is a syringe-based fluid delivery system for the delivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast media into a patient's vascular system for diagnostic imaging. Only trained healthcare professionals are intended to operate this device.
syringe-based fluid delivery system
This document is a 510(k) premarket notification approval letter for the Medrad Spectris Solaris Injector System. It does not contain information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes for training/testing, or expert qualifications.
The letter explicitly states that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices. This means that the manufacturer presented evidence to the FDA demonstrating that their device is as safe and effective as a device already on the market. The FDA approves the device based on this substantial equivalence, but the approval letter itself does not include the detailed study or performance data.
Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report or a summary of performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 4 2001
Ms. Lorraine R. Fredes Sr. Regulatory Affairs Coordinator Medrad, Incorporated One Medical Drive Indianola, PA 15051
K012950 Re:
Medrad Spectris Solaris Injector System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: August 31, 2001 Received: September 4, 2001
Dear Ms. Fredes:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becales on of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround, to region date of the Medical Device Amendments, or to devices that provision in way 26, 1976, and oneoutions of the Federal Food, Drug, and Cosmetic Ital ( both receined in are are aroval of a premarket approval application ( PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general androls 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 If your device to such additional controls. Existing major regulations affecting your device can be may or babyer to can about Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
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Page 2 - Ms. Lorraine R. Fredes
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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
ames 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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Intended Use
Indications for Use Statement
510(k) Number:
Device Name:
Medrad Spectris Solaris MR Injector
KO12950
Indications for Use:
The Spectris Solaris MR Injection System is a syringe-based fluid delivery system I ne Spectivery of contrast media during computed tomography applications. It is intended to be used for the specific purpose of injecting intravenous contrast is intended to be about for also specialisted on computed modially "this "the "hand healthcare professionals are intended to operate this device.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K012950 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (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.