(234 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is not available to provide further clues.
No
The device is used for the administration of contrast and flushing media, which assists in diagnosis rather than actively treating a condition.
No
The device is described as administering contrast media and flushing media in conjunction with MR imaging. This indicates it is an accessory used during the imaging process, not a device that itself processes data or produces a diagnosis.
No
The 510(k) summary describes a device for administering contrast media and flushing media, which inherently involves hardware components (e.g., pumps, tubing, syringes) to physically deliver the substances. The lack of a device description prevents confirmation, but the intended use strongly suggests a hardware-based system.
Based on the provided information, the EmpowerMR device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging." This describes a device used in vivo (within the body) for administering substances during a medical 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. They are performed outside the body.
The EmpowerMR device is clearly used within the body during an MR imaging procedure, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.
Product codes
JZQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance (MR) imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
API? 1 3 2007
E-Z-EM, Inc. c/o Ms. Tracey Campbell Director Regulatory Affairs 1111 Marcus Avenue Lake Success, NY 11042
Re: K062449
EW-Z-EM EmpowerMR Injector System and Fastload MR Syringe Pack Regulation Number: 21 CFR 870.1650 Regulation Name: Contrast Medium Injector Regulatory Class: II Product Code: JZQ Dated: April 4, 2007 Received: April 5, 2006
Dear Ms. Campbell:
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.
1
Page 2 - Ms. Tracey Campbell
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. lohner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
| 510(k) Application: | Abbreviated 510(k) K062449 |
|---|---|
| Device Name: | E-Z-EM EmpowerMR Injector System and Fastload MR Syringe Pack |
| Indications for Use: |
EmpowerMR: Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.
| Prescription Use | ✓ (Yes) |
|---|---|
| ------------------ | ---------------------- |
OR
| Over-the-Counter Use | ✗ (No) |
|---|---|
| ---------------------- | --------------------- |
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Volumy
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K062449
EmpowerMR, Ref. K062449
Attachment I