(89 days)
9240A, E8811JA
Not Found
No
The summary describes a passive cable used for cardiac gating in MR, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics associated with AI/ML algorithms.
No.
The device is a cable that helps with cardiac gating to improve MR image quality by reducing motion and flow artifacts, rather than directly treating a disease or condition.
No
The device is described as an ECG patient cable used for cardiac gating during MR applications to reduce motion and flow artifacts, not for diagnosing medical conditions.
No
The device description explicitly states it is a "four lead ECG patient cable" and a "cable," indicating it is a physical hardware component.
Based on the provided information, the GE High Impedance Cardiac Gating Cable 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 GE High Impedance Cardiac Gating Cable is a patient cable used to connect a patient to an MR scanner for the purpose of cardiac gating. This process involves synchronizing the MR imaging with the patient's heart rhythm to reduce motion artifacts.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a physical connection and signal transmission device used during an imaging procedure.
Therefore, the device's function falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GE high impedance cardiac gating cable is designed for MR applications where cardiac gating is required to reduce motion and flow artifacts. The cable may be used in the presence of surface coils.
Product codes
LNH
Device Description
The high impedance cardiac gating cable is a four lead ECG patient cable used for gating the MR scanner. The cable has a high distributed impedance to limit any RF currents induced into the cable by the MR scanner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
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
In-house as well as volunteer testing was completed. There was no significant heating of the cables and the cables gated the MR System properly.
Key Metrics
Not Found
Predicate Device(s)
Invivo Cables #9240A, GE Flat Film Leads #E8811JA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters "GE" intertwined within a circular border. A portion of the logo is cut off on the left side, giving it an incomplete appearance.
K981/190
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, March 25, 1998
- o Identification of the Product High Impedance Cardiac Gating Cables
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188
o Marketed Devices
The High Impedance Cardiac Gating Cable is substantially equivalent to the currently marketed Invivo Cables #9240A and the GE Flat Film Leads #E8811JA.
o Device Description
The high impedance cardiac gating cable is a four lead ECG patient cable used for gating the MR scanner. The cable has a high distributed impedance to limit any RF currents induced into the cable by the MR scanner.
o Indications for Use
The GE high impedance cardiac gating cable is designed for MR applications where cardiac gating is required to reduce motion and flow artifacts. The cable may be used in the presence of surface coils.
0 Comparison with Predicate
The GE high impedance cardiac gating cable is comparable to the Invivo cable in mechanical flexibility and with the GE Thin Film cable in regard to impedance.
o Summary of Studies
In-house as well as volunteer testing was completed. There was no significant heating of the cables and the cables gated the MR System properly.
o Conclusions
It is the opinion of GE that the High Impedance Cardiac Cables are substantially equivalent to the presently marketed cables. These cables do not include any new indications for use, nor does use of this cable result in any new potential hazards.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/3 description: The image shows a date stamp that reads "JUN 3 0 1998". The text is in a bold, sans-serif font. The date is likely stamped on a document or piece of paper. The image is in black and white.
Larry A. Kroger, Ph.D.
Senior Regulatory Affairs Programs Manager General Electric Systems P.O. Box 414. W-827 Milwaukee, Wisconsin 53201
Re:
K981190 High Impedance Cardiac Gating Cable Dated: March 25, 1998 Received: April 2, 1998 Regulator Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. Kroger:
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 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 (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. 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.
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 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" (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/cdrl/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: High Impedance Cardiac Gating Cable
Indications For Use:
The GE High Impedance Cardiac Gating Cable is designed for MR applications where cardiac gating is desired to reduce motion and flow artifacts. The cable may be used in the presence of surface coils.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K981190 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |