12SL ECG ANALYSIS PROGRAM

K092369 · Ge Medical Systems Information Technologies · MHX · Feb 24, 2010 · Cardiovascular

Device Facts

• Record ID: K092369
• Device Name: 12SL ECG ANALYSIS PROGRAM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm 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 patients' homes. ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.

Device Story

12SL ECG Analysis Program is a software-only algorithm; processes resting 12-lead ECG signals; provides automated interpretation of rhythm and contour information. Used in hospitals, clinics, emergency departments, ambulances, and homes; operated by physicians. Physician reviews, confirms, edits, or deletes automated output; assists in clinical decision-making for cardiac assessment. ACS Tool option provides specific analysis for adults with suspected acute coronary syndrome. Benefits include standardized, rapid initial interpretation of ECG data to support physician diagnosis.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification and validation, performance testing, and risk analysis.

Technological Characteristics

Software-only algorithm for ECG analysis. Operates on resting 12-lead ECG input. Complies with internal quality assurance measures including requirements reviews and risk analysis. No specific hardware or materials of construction; standalone software algorithm.

Indications for Use

Indicated for general population, including healthy subjects and patients with cardiac/non-cardiac abnormalities, for resting 12-lead ECG interpretation. ACS Tool option indicated for adult patients with suspected acute coronary syndrome.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 12SL EGG Analysis Program with Right Ventricular Analysis (K060833)

Submission Summary (Full Text)

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K092369 1/2

FEB 2 4 2010

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GE Healthcare 510(K) Premarket Notification Submission

## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: August 4, 2009 Date: GE Healthcare (GE Medical Systems Information Technologies) Submitter: 9900 Innovation Drive Wauwatosa, WI 53226 Primary Contact Person: Joe Lucas Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226 T: [phone] F: [phone] Kristin Pabst Secondary Contact Person: Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226 T: [phone] F: [phone] 12SL ECG Analysis Program Device: Trade Name: ECG Analysis Program Common/Usual Name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Classification Names: Alarms) 74MHX 21CFR 870.1025 Product Code: K060833; 12SL EGG Analysis Program with Right Ventricular Predicate Device(s): Analysis The 12SL ECG Analysis Program is a software algorithm only. Device Description: The 12SL ECG Analysis Program assists the physician in Intended Use: measuring and interpreting resting 12-lead ECGs for rhythm 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 patients' homes. ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.

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Appendix A

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K0923672/2

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GE Healthcare 510(K) Premarket Notification Submission

| <b>Technology:</b> | The 12SL ECG Analysis Program employs the same functional scientific technology as its predicate device. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Determination of Substantial Equivalence:</b> | Summary of Non-Clinical Tests: |
| | There are no recognized consensus standards applicable to the 12SL ECG Analysis System algorithm. The 12SL ECG Analysis Program and its applications comply with the Guidances and/or Special Controls as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system: |
| | <ul><li>Requirements Reviews</li><li>Risk Analysis</li><li>Software Verification and Validation</li><li>Performance testing</li></ul> |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, 12SL ECG Analysis Program, did not require clinical studies to support substantial equivalence. |

- GE Healthcare considers the 12SL ECG Analysis Program to be Conclusion: as safe, as effective, and performance is substantially equivalent to the predicate device.
. .

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

## EEB 8 4 2010

GE Medical Systems Information Technologies c/o Joseph Lucas, Regulatory Leader 9900 Innovation Drive Wauwatosa, WI 53226

Re: K092369

Trade/Device Name: 12SL ECG Analysis Program Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms) Regulatory Class: Class II (special controls) Product Code: MHX Dated: February 15, 2010 Received: February 18, 2010

Dear Mr. Lucas:

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 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.

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); medical device reporting (reporting of medical

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Page 2 - Mr. Joseph Lucas

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GE Healthcare 510(K) Premarket Notification Submission

510(k) Number: K092369

12SL ECG Analysis Program Device Name:

Indications for Use:

The 12SL ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead ECGs for rhythm 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 patients' homes.

ACS Tool option is intended for adult patient population who are suspected clinically to have acute coronary syndrome.

Prescription Use_X_ 1 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

| (Division Sign-Off) |
|------------------------------------|
| Division of Cardiovascular Devices |

| 510(k) Number | k092369 |
|---------------|---------|
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