(127 days)
The 12SL ECG Analysis Program with Right Ventricular Analysis assists the physician in interpreting resting 12-lead ECGs for rhythms and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of-hospital sites such as ambulances and patient's homes.
The 12SL ECG Analysis Program with Right Ventricular Analysis is a software algorithm only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 12SL ECG Analysis Program with Right Ventricular Analysis (K060833):
Acceptance Criteria and Device Performance Study for 12SL ECG Analysis Program with Right Ventricular Analysis (K060833)
Based on the provided 510(k) summary, specific, quantifiable acceptance criteria and a detailed study report are not explicitly provided. The submission focuses on substantial equivalence to a predicate device (K042177 MAC 5000 ECG Analysis System and K002209 12SL ECG Analysis Program) and compliance with voluntary standards.
The "Test Summary" section states: "The 12SL ECG Analysis System with Right Ventricular Analysis complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system: Risk Analysis, Requirement Specification Reviews, Code Inspections, Software Verification and Validation Testing." And concludes, "The results of these measurements demonstrated that the 12SL ECG Analysis System with Right Ventricular Analysis is as safe, as effective, and performs as well as the predicate devices."
This indicates that the acceptance criteria likely revolved around demonstrating performance comparable to the predicate devices, rather than predefined quantitative thresholds for diagnostic accuracy metrics (e.g., sensitivity, specificity) for specific cardiac conditions. The testing was focused on software verification and validation to ensure the algorithm functioned as intended and delivered results consistent with the predicate.
Given this, the following sections will reflect the information available in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Submission) | Reported Device Performance |
|---|---|
| Compliance with voluntary standards (as detailed in Section 9 of the submission - details not provided in excerpt) | "The 12SL ECG Analysis System with Right Ventricular Analysis complies with the voluntary standards as detailed in Section 9 of this submission." |
| Performance as safe, as effective, and as well as the predicate devices (K042177 MAC 5000 ECG Analysis System and K002209 12SL ECG Analysis Program) | "The results of these measurements demonstrated that the 12SL ECG Analysis System with Right Ventricular Analysis is as safe, as effective, and performs as well as the predicate devices." (Implies that testing confirmed comparable output and functionality, but specific quantitative metrics comparing to predicate are not detailed in this summary.) The submission states the device "employs the same functional technology as the predicate devices," implying that expected performance would be similar. |
| Successful completion of quality assurance measures (Risk Analysis, Requirement Specification Reviews, Code Inspections, Software Verification and Validation Testing) | "The following quality assurance measures were applied to the development of the system: Risk Analysis, Requirement Specification Reviews, Code Inspections, Software Verification and Validation Testing." (Implies all these measures were successfully completed, confirming software integrity and functionality per internal specifications.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Test Summary" mentions "Software Verification and Validation Testing" but does not elaborate on the datasets used for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth for any test set or their qualifications. The device's intended use states that its "initial automated interpretation" is "then confirmed, edited, or deleted by the physician," suggesting ongoing human expert involvement in clinical practice, but not necessarily in the validation study itself as described in this summary.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method (e.g., 2+1, 3+1, none) used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Based on the provided summary, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance does not appear to have been done or, at least, is not reported in this summary. The focus is on the stand-alone performance and substantial equivalence to existing predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance assessment was done, implicitly. The "Test Summary" and the general nature of a software algorithm submission for substantial equivalence imply that the algorithm's performance was evaluated independently. The device itself is described as a "software algorithm only" that provides "an initial automated interpretation." The validation described as "Software Verification and Validation Testing" would primarily assess the algorithm's output in a standalone capacity against some form of ground truth or expected output.
7. The Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used for any testing. Given the comparison to predicate devices, it's plausible that the ground truth for validation involved:
- Comparison with interpretations from the predicate 12SL ECG Analysis Program.
- Expert consensus from board-certified cardiologists or physicians specializing in ECG interpretation.
- Potentially, correlation with clinical outcomes or other diagnostic tests, though this is less likely to be the primary ground truth for a pure ECG interpretation algorithm's 510(k).
8. The Sample Size for the Training Set
The provided text does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not specify how the ground truth for any training set was established. Given that the device "employs the same functional technology as the predicate devices," it's possible that the core algorithm (and thus its training, if any, or rule-based expert system development) relied on previously established and validated methodologies used for the predicate devices.
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AUG () 1 2006
| Section 2 Summary | |
|---|---|
| 510(k) Summary of Safety and Effectiveness | |
| Date: | March 17, 2006 |
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223USA |
| Contact Person: | Lisa M. BaumhardtRegulatory Affairs Program ManagerGE Medical Systems Information TechnologiesPhone: 414-362-3242Fax: 414-362-2585 |
| Device:Trade Name:Common/Usual Name: | 12SL ECG Analysis Program with Right Ventricular AnalysisECG Analysis Program |
| Classification Names:21 CFR 870.1025Predicate Device: | Monitor, Physiological Patient (with Arrhythmia Detection or Alarms)74MHXK042177 MAC 5000 ECG Analysis System |
| Device Description: | K002209 12SL ECG Analysis ProgramThe 12SL ECG Analysis Program with Right Ventricular Analysis is asoftware algorithm only. |
| Intended Use: | The 12SL ECG Analysis Program assists the physician in interpretingresting 12-lead ECGs for rhythms and contour information by providingan initial automated interpretation. Interpretation by the product is thenconfirmed, edited, or deleted by the physician. The analysis program isintended for use in the general population ranging from healthy subjectsto patients with cardiac and/or non-cardiac abnormalities. The analysisprogram is intended for use in hospitals, outpatient clinics, emergencydepartments, and out-of-hospital sites such as ambulances andpatient's homes. |
| Technology: | The 12SL ECG Analysis System with Right Ventricular Analysisemploys the same functional technology as the predicate devices. |
| Test Summary: | The 12SL ECG Analysis System with Right Ventricular Analysiscomplies with the voluntary standards as detailed in Section 9 of thissubmission. The following quality assurance measures were applied tothe development of the system:Risk AnalysisRequirement Specification Reviews�Code InspectionsSoftware Verification and Validation Testing |
| Conclusion: | The results of these measurements demonstrated that the 12SL ECGAnalysis System with Right Ventricular Analysis is as safe, as effective,and performs as well as the predicate devices. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 1 2006
GE Medical Information Technologies c/o Ms. Lisa M. Baumhardt, M.T. Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, WI 53223
Re: K060833
Koooooo
Trade Name: 12SL ECG Analysis System with Right Ventricular Analysis Regulation Number: 21 CFR 870.1025 Regulation Name: 21 CFR 0781722
Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm). Regulatory Class: Class II (two) Product Code: MHX Dated: July 27, 2006 Received: July 28. 2006
Dear Ms. Baumhardt:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we nave reviewed your Section 510(x) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manated prought of the Medical Device Amendments, or to commerce prof to May 28, 1776, the enactions with the provisions of the Federal Food, Drug. devices that have been it classified in accordance what a premarket approval applicians of the Act . The and Costlette Act (Act) that do not require approvinces were al controls provisions of the Act. The Act. The You may, therefore, market the device, baoject to meetirements for annual registration. Ilish and general controls provisions of the Fret Herwas - a adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). in if your device is classifica (Sec above) into efficial on affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controlise "Extrems" sonothy" some 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lisa M. Baumhardt, M.T.
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 no 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 reauirements; 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimura 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):
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12SL ECG Analysis System with Right Ventricular Analysis Device Name:
Indications For Use:
The 12SL ECG Analysis System with Right Ventricular Analysis assists the physician in interpreting resting 12-lead ECGs for rhythms and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of-hospital sites such as ambulances and patient's homes.
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)
Bhummer
(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K060833
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.