SEER MC

K042782 · Ge Medical Systems Information Technologies · MLO · Sep 2, 2005 · Cardiovascular

Device Facts

• Record ID: K042782
• Device Name: SEER MC
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MLO · Cardiovascular
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The SEER MC recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded data. Results of the automated analysis when used in conjunction with an ECG review system are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) human patients in a clinical setting by qualified medical personnel.

Device Story

SEER MC is a Holter recorder for ambulatory ECG monitoring; collects/stores up to 48 hours of continuous 2/3-channel ECG or periodic/on-demand 12-lead ECG data. Device digitizes and performs automated waveform measurements during recording. Used in clinical settings by qualified medical personnel. Output transferred to ambulatory ECG review system for physician interpretation. Automated analysis assists in identifying heart rate, rhythm, ST segment trends, and morphology. Provides data for clinical decision-making regarding arrhythmias, ischemia, and pacemaker function. Not a substitute for diagnostic-quality 12-lead ECG.

Clinical Evidence

Bench testing only. Quality assurance measures included requirements specification review, risk analysis, software/hardware testing, performance testing, safety testing, environmental testing, and clinical use evaluation. Final validation confirmed device is as safe and effective as predicate devices.

Technological Characteristics

Ambulatory digital Holter recorder; 2/3-channel continuous or 12-lead periodic/on-demand ECG acquisition. Connectivity via ambulatory ECG review system. Software-based automated analysis for waveform measurements, heart rate, rhythm, and ST segment trending. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult and pediatric (>10kg) patients in clinical settings for ambulatory ECG monitoring to evaluate symptoms of cardiac arrhythmia, conduction disturbances, or myocardial ischemia; detect ECG events altering prognosis in heart disease; analyze pacemaker function/failure; determine cardiac response to lifestyle; and evaluate therapeutic interventions or epidemiological/clinical trial data.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• SEER (K882818)
• Mortara H12+ Holter Recorder (K021373)

Submission Summary (Full Text)

{0}------------------------------------------------

# SEP 0 2 2005

### Section 2 Summary

510(k) Summary of Safety and Effectiveness

| Date: | October 4, 2004 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Grace LeMieux<br>Regulatory Affairs Manager<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: | |
| Trade Name: | SEER MC |
| Common/Usual Name: | Holter Recorder |
| Classification Names: | 21 CFR 870.2800 Electrocardiograph, ambulatory, with analysis algorithm |
| Predicate Devices: | SEER® (K882818)<br>Mortara H12+ Holter Recorder (K021373) |
| Device Description: | SEER MC is a Holter Recorder designed to be used in conjunction with an<br>ambulatory ECG system to assist in the diagnosis and assessment of patients.<br>The SEER MC acquires, digitizes, stores and analyzes data for scanning and<br>review by an ambulatory ECG review system. SEER MC can collect and store<br>up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In<br>addition, the SEER MC can record and analyze 12 lead ambulatory ECG data<br>periodically or on demand. This analysis performs waveform measurements.<br>These measurements are performed during recording for use in analysis and<br>review within the ambulatory ECG review system. |

The SEER MC recorder is intended to provide ambulatory ECG signal and Intended Use: automated analysis of the recorded data. Results of the automated analysis when used in conjunction with an ECG review system are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze12-lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) human patients in a clinical setting by qualified medical personnel. Ambulatory ECG monitoring is useful for the following indications:

- Evaluation of symptoms that may be caused by cardiac arrhythmia . and/or conduction disturbances
- Evaluation of symptoms that may be due to myocardial ischemia .
- Detection of ECG events that alter prognosis in certain forms of heart ● disease
- Detection and analysis of pacemaker function and failure .
- Determination of cardiac response to lifestyle .
- Evaluation of therapeutic interventions .

Investigations in epidemiology and clinical trials

SEER MC is not intended to be used as a substitute for a standard, diagnostic-

{1}------------------------------------------------

<0-42792
p 2/2

7

quality 12-lead electrocardiograph.

- Technology: The proposed SEER MC employs the same functional scientific technology as the predicate devices SEER (K882818) and Mortara H12+ (K021373).
- The SEER MC complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission. The following quality assurance measures were applied to the development of the device:
- . Requirements specification review
- Risk analysis .
- . Software and hardware testing
- . Performance testing
- . Safety testing
- Environmental testing .
- Clinical use evaluation .
- Final validation
- Conclusion: The results of these measurements demonstrated that the SEER MC is as safe, as effective, and performs as well as the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's head and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

General Electric Medical Systems Information Technologies c/o Ms. Lisa M. Baumhardt Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K042782

Trade Name: SEER MC Ambulatory Digital Analysis Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLO Dated: July 6, 2005 Received: July 8, 2005

Dear Ms. Baumhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(x) pressure 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 regally to regally the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, devices mat have been reculise in quire approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not require appent a fre
You may, therefore, market the device, subject to the general controls provisions of the Act. The f ou may, merciole, manot the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is crassified (see abor of als. Existing major regulations affecting your device can may be subject to suen additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 – Ms. Lisa M. Baumhardt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted other requirements of the Act
that FDA has made a determination that your device with other requirements of the Act that FDA has made a determination that your device on the Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listin or any Federal statutes and regulations administed or rotlimited to : egistration and listing
comply with all the Act's requirements, including arectice requirements a comply with all the Act's requirements, metuding, out mor macuring practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice req (21 CFR Part 807); labeling (21 CFR Pati 801); good manatotanas pamicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patter at); 21 CFR 1000-1050 forth in the quality systems (QS) regulation (21 -512 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Scctions 31 device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to begin marketing your article quisales of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your de premarket notification. The FDA inding of substantial equive 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
rs and the many of the may or and 0005 - Alge masses note the regulation en If you desire specific advice for your uevice on our lacemite the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation o contact the Office of Compliance at (240) 270 - 270 - 270 - 1207.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reterence to prematicallities under the Act from the Division of Small
other general information on your responsibilities under the Act from world 1800) 638-2 other general information on your responsibilities under (800) -free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-fremamain html Manufacturers, International and Consumer Absteaner and world driver and main.html

Sincerely yours,

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):

Page 1 of 1

## Device Name: SEER MC Ambulatory Digital Analysis Recorder

Indications For Use:

The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECC data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel.

The SEER MC in its 2 or 3 channel mode of operation detects the following: normal beats, ventricular beats, supraventricular beats, paced beats and artifact. This information with an ECG review system, documents the following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms.

The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the afforementioned information and also measures and trends the following 12 lead parameters: PR interval, QT interval, QRS diration, ST measurements at J point plus 40, 60 and 80 mseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment.

The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.

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)

vices
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042787