(178 days)
Not Found
No
The description focuses on signal reconstruction based on existing channels, without mentioning AI/ML techniques or providing details about training/test data sets typically associated with such technologies.
No
Explanation: The device is intended for generating ECG reports and monitoring, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section states: "The product is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment." This indicates its role in the diagnostic process.
No
The device description explicitly states that the software feature is used "when at least six electrodes are attached to a patient," indicating a reliance on hardware (electrodes and likely an ECG acquisition device) to acquire the initial data. The software then processes this data, but it is not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device function: The GE 12RL program processes electrocardiograph (ECG) signals acquired directly from the patient's body through electrodes. It reconstructs and presents these signals as a 12-lead ECG report.
- No sample analysis: The device does not analyze samples taken from the body (like blood or urine). It directly processes electrical signals from the body.
Therefore, the GE 12RL program falls under the category of a medical device that directly interacts with the patient's body to acquire physiological data, rather than an in vitro diagnostic device that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The 12RL feature is intended to reconstruct electrocardiograph (ECG) signals such that a 12-lead ECG presentation can be made when at least six electrodes are attached to a patient. These 12-lead ECGs may be 10 second records or continuous recordings suitable for ST segment trending.
The GE 12RL program generates a 12-lead ECG report from a subset of the electrodes used to acquire a standard 12 lead ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG.
The four signals generated by the GE 12RL program are similar but not identical to the standard 12-lead ECG. All ECG data generated via 12RL are clearly identified as to which channels have been synthesized.
The GE 12RL program is intended for use in a monitoring environment. Computerized measurements may be generated from these data; however, a computerized interpretation will not.
The product is intended for use in the general adult population ranging from healthy subjects to patients with cardiac and/or noncardiac abnormalities.
The product is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.
Product codes
DRT, DPS, DSI, DQK, DXH
Device Description
The 12RL feature is intended to reconstruct electrocardiograph (ECG) signals such that a 12-lead ECG presentation can be made when at least six electrodes are attached to a patient. These 12-lead ECGs may be 10 second records or continuous recordings suitable for ST segment trending. The GE 12RL program generates a 12-lead ECG report from a subset of the electrodes used to acquire a standard 12 lead ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
general adult population
Intended User / Care Setting
monitoring environment
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 12RL complies with the voluntary standards as detailed in Test Summary: Section 9 of this submission. The following quality assurance measures were applied to the development of the 12RL program:
- Risk Analysis.
- Requirements Specification Review.
- Code Inspections.
- Software Verification and Validation Testing.
The results of these measurements demonstrated that the 12RL Conclusion: program is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Section 2 Summary of Safety and Effectiveness
| Date: | July 28, 2006 | |||
|---|---|---|---|---|
| Submitter: | GE Medical Systems Information Technologies | |||
| 8200 West Tower Avenue | ||||
| Milwaukee, WI 53223 USA | AUG - 4 2006 | |||
| Contact Person: | Adrienne Lenz | |||
| Quality Engineer | ||||
| GE Medical Systems Information Technologies | ||||
| Phone: 414-721-3245 | ||||
| Fax: 414-721-3863 | ||||
| Email: Adrienne.Lenz@ge.com | ||||
| Device: | ||||
| Trade | ||||
| Name: | Twelve Lead Transformation Function, "12RL" | |||
| Common/Usual | ||||
| Name: | 12RL | |||
| Classification | ||||
| Names: | 21 CFR 870.2300 Cardiac monitor | 74DRT | ||
| 21 CFR 870.2340 Electrocardiograph | 74DPS | |||
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | 74DSI | |||
| 21 CFR 870.1425 Programmable diagnostic | ||||
| computer | 74DQK | |||
| 21 CFR 870.2920 Transmitters and Receivers, | ||||
| Electrocardiograph, Telephone | 74DXH | |||
| Predicate Device: | 1 K992595 | |||
| 2 K030738 | ||||
| 3 K964750 | 1 EASI | |||
| 2 TruST | ||||
| 3 Marquette Eagle 4000 | 1 Philips | |||
| 2 Siemens | ||||
| 3 GE Medical Systems | ||||
| Information | ||||
| Technologies |
The 12RL feature is intended to reconstruct electrocardiograph Device Description: (ECG) signals such that a 12-lead ECG presentation can be made when at least six electrodes are attached to a patient. These 12-lead ECGs may be 10 second records or continuous recordings suitable for ST segment trending.
1
The GE 12RL program generates a 12-lead ECG report from a Intended Use: subset of the electrodes used to acquire a standard 12 lead ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG.
The four signals generated by the GE 12RL program are similar but not identical to the standard 12-lead ECG. All ECG data generated via 12RL are clearly identified as to which channels have been synthesized.
The GE 12RL program is intended for use in a monitoring environment. Computerized measurements may be generated from these data; however, a computerized interpretation will not.
The product is intended for use in the general adult population ranging from healthy subjects to patients with cardiac and/or noncardiac abnormalities.
The product is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.
- Technology: The 12RL technology is based on linear equations as is used by the predicate devices. Therefore there is no change in technology.
- The 12RL complies with the voluntary standards as detailed in Test Summary: Section 9 of this submission. The following quality assurance measures were applied to the development of the 12RL program:
- Risk Analysis .
- Requirements Specification Review .
- Code Inspections .
- Software Verification and Validation Testing .
- The results of these measurements demonstrated that the 12RL Conclusion: program is as safe, as effective, and performs as well as the predicate device.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and two curved lines representing its legs. The seal is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2006
GE Healthcare Information Technologies c/o Ms. Adrienne Lenz Regulatory Affairs Specialist 9900 Innovation Drive Wauwatosa, WI 53226
Re: K060307
Trade Name: 12 Lead Transformation Function, "12RL" Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: DRT Dated: July 28, 2006 Received: July 31, 2006
Dear Ms. Lenz:
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.
3
Page 2 – Ms. Adrienne Lenz
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bfremmima for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K060307
Device Name: 12 RL Algorithm
Indications For Use:
The GE 12RL program generates a 12-lead ECG report from a subset of the electrodes used to acquire a standard 12 Icad ECG. Four of the precordial channels of the 12-lead ECG (V2, V3, V4, V6) are not acquired from the patient; rather, they are reconstructed from information that is directly recorded in the other channels of the 12-lead ECG.
The four signals generated by the GE 12RL program are similar but not identical to the standard 12-lead ECG. All ECG data generated via 12RL are clearly identified as to which channels have been synthesized.
The GE 12RL program is intended for use in a monitoring environment. Computerized measurements may be generated from these data; however, a computerized interpretation will not.
The product is intended for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
The product is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.
Prescription Use X (Per 21 CFR 801.109 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Blummenauer
Division Sign Off
IDivision Sian-Off Division of Cardlovascular Devices 510(k) Number