(89 days)
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.
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.
This document describes a 510(k) submission for a medical device, specifically a "High Impedance Cardiac Gating Cable" manufactured by GE Medical Systems. The assessment focuses on establishing substantial equivalence to existing predicate devices, rather than proving novel performance. Therefore, the information provided relates more to validation against established safety and functionality standards for this type of accessory.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a non-diagnostic accessory, the "acceptance criteria" are primarily related to safety and functional equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity or specificity.
| Acceptance Criteria (Indirectly Derived) | Reported Device Performance |
|---|---|
| Absence of significant heating during use | "There was no significant heating of the cables." |
| Proper cardiac gating of the MR system | "The cables gated the MR System properly." |
| Substantial equivalence in mechanical flexibility | "Comparable to the Invivo cable in mechanical flexibility." |
| Substantial equivalence in impedance | "Comparable... with the GE Thin Film cable in regard to impedance." |
| No new indications for use | "These cables do not include any new indications for use." |
| No new potential hazards | "nor does use of this cable result in any new potential hazards." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The summary mentions "in-house as well as volunteer testing." The number of volunteers and the specific sample size for "in-house" testing are not provided.
- Data Provenance: The testing was conducted "in-house" and involved "volunteer testing." This implies prospective data collection, likely within the United States (given GE Medical Systems' address in Milwaukee, WI, USA). Specific country of origin for volunteers is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of this device. This device is an accessory cable for MRI machines, not a diagnostic algorithm that requires expert interpretation for ground truth establishment. The "ground truth" here is the physical performance and safety of the cable itself (e.g., whether it heats up, whether it gates correctly).
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is about device performance, not diagnostic classification requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an accessory, not an AI diagnostic algorithm.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI algorithm; it's a physical cable. The performance described ("no significant heating," "gated the MR System properly") is the standalone performance of the physical device.
7. Type of Ground Truth Used
The "ground truth" for this device's performance was based on:
- Direct Measurement/Observation for physical properties (e.g., temperature measurements for heating, observation of proper gating by MR system).
- Comparison to predicate devices for characteristics like flexibility and impedance to establish "substantial equivalence."
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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.
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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
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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.
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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 |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
N/A