(178 days)
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 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.
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 provided text is a 510(k) summary for the GE 12RL (Twelve Lead Transformation Function) device, which reconstructs specific ECG leads. However, it does not contain a detailed study description with acceptance criteria and reported device performance. It primarily focuses on regulatory approval, predicate devices, and general statements about safety and effectiveness based on internal quality assurance measures.
Therefore, I cannot fulfill all parts of your request with the provided input. I will extract the available information and explicitly state where the requested details are missing.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided directly from the text. The document states: "The results of these measurements demonstrated that the 12RL program is as safe, as effective, and performs as well as the predicate device." This is a conclusion, not specific acceptance criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from the text. The document does not mention any specific test set, sample sizes, or data provenance for a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided from the text. There is no mention of an expert panel or ground truth establishment process for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided from the text. There is no mention of adjudication for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done, or at least not described. The document implies internal "Software Verification and Validation Testing" and "Risk Analysis" but no external or comparative effectiveness study involving human readers is mentioned. This device reconstructs ECG signals; it does not directly "assist" human readers in the way an AI diagnostic tool might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied, but not detailed. The "Software Verification and Validation Testing" would likely involve evaluating the algorithm's output against some reference, which is a form of standalone testing. However, no specific details of this testing (e.g., metrics, methodology) are provided. The product description states: "Computerized measurements may be generated from these data; however, a computerized interpretation will not." This confirms it's an algorithm-only output device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided from the text. The document does not describe how ground truth was established for any testing. For an ECG signal reconstruction device, "ground truth" would typically be the directly acquired 12-lead ECG signals themselves, against which the reconstructed signals are compared. However, this is not explicitly stated as the methodology.
8. The sample size for the training set
- Cannot be provided from the text. No training set or its size is mentioned.
9. How the ground truth for the training set was established
- Cannot be provided from the text. No training set or ground truth establishment for it is mentioned.
Summary of Available Information:
The document describes the GE 12RL (Twelve Lead Transformation Function) device, which reconstructs four precordial ECG channels (V2, V3, V4, V6) from other acquired 12-lead ECG channels.
The regulatory submission primarily relies on:
- Technology: The 12RL technology is based on linear equations, similar to predicate devices.
- Quality Assurance Measures:
- Risk Analysis
- Requirements Specification Review
- Code Inspections
- Software Verification and Validation Testing
- Conclusion: Based on these measures, the 12RL program is deemed "as safe, as effective, and performs as well as the predicate device."
Missing Information:
Crucially, the provided text does not contain any specific acceptance criteria, reported performance metrics, details of a clinical study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any information regarding AI assistance effects or training set details. The submission focuses on demonstrating substantial equivalence through internal development processes and technological similarity to predicate devices rather than a detailed performance study with quantitative results against specific criteria.
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Section 2 Summary of Safety and Effectiveness
| Date: | July 28, 2006 | |||
|---|---|---|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA | AUG - 4 2006 | ||
| Contact Person: | Adrienne LenzQuality EngineerGE Medical Systems Information TechnologiesPhone: 414-721-3245Fax: 414-721-3863Email: Adrienne.Lenz@ge.com | |||
| Device:TradeName: | Twelve Lead Transformation Function, "12RL" | |||
| Common/UsualName: | 12RL | |||
| ClassificationNames: | 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 diagnosticcomputer | 74DQK | |||
| 21 CFR 870.2920 Transmitters and Receivers,Electrocardiograph, Telephone | 74DXH | |||
| Predicate Device: | 1 K9925952 K0307383 K964750 | 1 EASI2 TruST3 Marquette Eagle 4000 | 1 Philips2 Siemens3 GE Medical SystemsInformationTechnologies |
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.
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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.
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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.
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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
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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
§ 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).