12SL ECG ANALYSIS PROGRAM

K060833 · Ge Medical Systems Information Technologies · MHX · Aug 1, 2006 · Cardiovascular

Device Facts

• Record ID: K060833
• Device Name: 12SL ECG ANALYSIS PROGRAM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 1, 2006
• Decision: SESE
• Submission Type: Special
• 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 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.

Device Story

12SL ECG Analysis Program with Right Ventricular Analysis is software-only algorithm; processes resting 12-lead ECG signals; provides automated interpretation of rhythms and contour information; intended for use by physicians in hospitals, clinics, emergency departments, ambulances, and homes; physician confirms, edits, or deletes automated output; assists in clinical decision-making by providing initial interpretation; benefits patient through rapid ECG analysis.

Clinical Evidence

No clinical data. Bench testing only, including risk analysis, requirement specification reviews, code inspections, and software verification and validation testing.

Technological Characteristics

Software-only algorithm; 12-lead ECG analysis; intended for integration into ECG systems; software verification and validation per quality assurance measures.

Indications for Use

Indicated for interpretation of resting 12-lead ECGs in general population, including healthy subjects and patients with cardiac or non-cardiac abnormalities.

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

• MAC 5000 ECG Analysis System (K042177)
• 12SL ECG Analysis Program (K002209)

Submission Summary (Full Text)

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K060833

AUG () 1 2006

| Section 2 Summary | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Summary of Safety and Effectiveness | |
| Date: | March 17, 2006 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223<br>USA |
| Contact Person: | Lisa M. Baumhardt<br>Regulatory Affairs Program Manager<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name:<br>Common/Usual Name: | 12SL ECG Analysis Program with Right Ventricular Analysis<br>ECG Analysis Program |
| Classification Names:<br>21 CFR 870.1025<br>Predicate Device: | Monitor, Physiological Patient (with Arrhythmia Detection or Alarms)<br>74MHX<br>K042177 MAC 5000 ECG Analysis System |
| Device Description: | K002209 12SL ECG Analysis Program<br>The 12SL ECG Analysis Program with Right Ventricular Analysis is a<br>software algorithm only. |
| Intended Use: | The 12SL ECG Analysis Program assists the physician in interpreting<br>resting 12-lead ECGs for rhythms and contour information by providing<br>an initial automated interpretation. Interpretation by the product is then<br>confirmed, edited, or deleted by the physician. The analysis program is<br>intended for use in the general population ranging from healthy subjects<br>to patients with cardiac and/or non-cardiac abnormalities. The analysis<br>program is intended for use in hospitals, outpatient clinics, emergency<br>departments, and out-of-hospital sites such as ambulances and<br>patient's homes. |
| Technology: | The 12SL ECG Analysis System with Right Ventricular Analysis<br>employs the same functional technology as the predicate devices. |
| Test Summary: | The 12SL ECG Analysis System with Right Ventricular Analysis<br>complies with the voluntary standards as detailed in Section 9 of this<br>submission. The following quality assurance measures were applied to<br>the development of the system:<br>Risk Analysis<br>Requirement Specification Reviews<br>�<br>Code Inspections<br>Software Verification and Validation Testing |
| Conclusion: | The results of these measurements demonstrated that the 12SL ECG<br>Analysis System with Right Ventricular Analysis is as safe, as effective,<br>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 [phone]. 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 [phone] or [phone] 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