(83 days)
Not Found
No
The description focuses on a signal processing technique (retrospective gating) and explicitly states no hardware changes. There is no mention of AI/ML terms or data-driven training/testing.
No
The device is described as a cardiac gating technique for producing images of the heart, which is a diagnostic function, not a therapeutic one.
No
The device is described as a cardiac gating technique for producing images of the heart. Its purpose is to acquire images, not to diagnose a condition. The "Intended Use" states "The production of a series of images of the heart," which is an imaging function, not a diagnostic one.
No
The device is described as a "modification" to existing MRI systems (predicate devices) and is a "cardiac gating technique." While it doesn't involve hardware changes, it's a software-based feature or functionality integrated into a larger hardware system (the MRI scanner) to improve image acquisition. It's not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "The production of a series of images of the heart at different phases of the cardiac cycle." This describes an imaging process, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details a modification to an MRI system's gating technique. MRI is an in vivo (within the body) imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices.
The device is clearly an imaging system modification used for diagnostic purposes in vivo, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The production of a series of images of the heart at different phases of the cardiac cycle.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The modification is a cardiac gating technique referred to as Retrospective Gating. In standard cardiac gating, the acquisition is triggered by the QRS pulse of the ECG. In Retrospective Gating, the scan runs continuously, and the correlation with the QRS cycle is done after the fact. This modification does not involve any changes to the existing hardware of the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Heart
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)
The MRI performance parameters remain unchanged. The Retrospective Gating option produces images that are comparable with those produced using the standard cardiac gating technique.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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510(k) Summary
K974614
-
- Submitter's Name and Address: Elscint, Inc., 505 Main Street, Hackensack, NJ 07601
Contact Person and Telephone No.: Steven M. Kay, (201) 342-2020 MAR - 4 1998
- Submitter's Name and Address: Elscint, Inc., 505 Main Street, Hackensack, NJ 07601
10 December 1997 Date of Summary:
- Retrospective Gating for Elscint MRI Systems 2. Device Name: Retrospective Gating for Elscint MRI System Trade/Proprietary Name: MRI System Modification Common Name: Magnetic Resonance Diagnostic Device Classification Name:
- Gyrex 2T Prestige system (K945791), Gyrex Privilege 3. Predicate Device(s): System (K954039), Gyrex Prima 1 TG System (K970990)
4. Device Description:
The modification is a cardiac gating technique referred to as Retrospective Gating. In standard cardiac gating, the acquisition is triggered by the QRS pulse of the ECG. In Retrospective Gating, the scan runs continuously, and the correlation with the QRS cycle is done after the fact. This modification does not involve any changes to the existing hardware of the predicate devices.
5. Intended Use:
| Anatomical Region: | Heart |
|---|---|
| Nuclei Excited: | Hydrogen |
| Diagnostic Use: | Production of a series of images of the heart at different |
| phases of the cardiac cycle. |
6. Safety:
- The MRI safety parameters, SAR, dB/dt, Bo, and acoustic noise, are unchanged by the . current modification.
- Electrical, mechanical, and biocompatibility safety issues are unchanged by the current . modification.
- No new software hazards have been introduced, so the software level of concern remains . minor.
- The current modification does not affect the site planning, installation, or service . manuals, and do not require any new safety labeling.
1
7. Effectiveness:
The MRI performance parameters remain unchanged. The Retrospective Gating option produces images that are comparable with those produced using the standard cardiac gating technique.
8. Equivalency Information Summary:
The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the modified devices is similar to that of the predicate devices. It is Elscint's opinion that the Prestige, Privilege and Prima systems with the new Retrospective Gating option are substantially equivalent to their predicate devices in terms of safety and effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Beny Sherer Safety Officer Elscint, Inc. 86 Orchard Street Hackensack, NJ 07601 Re:
MAR - 4 1998
Gyrex 2T Prestige, Privilege and Prima ITG with Retrospective Gating Dated: December 10, 1997 Received: December 11, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Sherer:
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 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 Fecteral 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 (OS) 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. 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.
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) 594-4613. Additionally, for question 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" (21 CFR 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/odrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yih
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Far. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_K 974614
Device Name: Retrospective Gating for Elscint MRI Systems
Indications For Use:
The production of a series of images of the heart at different phases of the cardiac cycle.
(Please do not write below this line - continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation (ODE))
Schmid C. Seyfarth
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
(
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________