SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM

K050731 · Ge Medical Systems Information Technologies · MWJ · May 19, 2005 · Cardiovascular

Device Facts

• Record ID: K050731
• Device Name: SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MWJ · Cardiovascular
• Decision Date: May 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SEER Light Extend Compact Digital Holter System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. The device stores this data along with patient demographic information to on board flash memory. The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.

Device Story

Device acquires ambulatory 2 or 3 channel ECG signals from chest surface; stores data and patient demographics on-board flash memory. Used in hospital or medical facility by trained operators under licensed practitioner supervision. Controller or USB interface (SEER Light Connect) downloads demographics to recorder and verifies signal quality at hookup. Post-recording, data transferred to controller or PC via cable/interface for storage on compact flash memory card. Device performs no ECG analysis; provides raw data for clinical review. Benefits include continuous cardiac monitoring for up to 48 hours to assist in diagnosis.

Clinical Evidence

No clinical data. Bench testing only, including risk analysis, requirements/design reviews, unit-level module verification, system integration testing, final acceptance validation, performance testing, safety testing, and environmental testing.

Technological Characteristics

Ambulatory 2 or 3 channel ECG recorder; on-board flash memory storage; compact form factor. Connectivity via cable or USB interface (SEER Light Connect) to controller or PC. No automated ECG analysis. Powered by internal battery. Complies with voluntary standards for medical electrical equipment.

Indications for Use

Indicated for acquisition of ambulatory 2 or 3 channel ECG signals from chest surface of pediatric and adult patients weighing 10Kg or more. Contraindicated for patients weighing less than 10Kg.

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 Light Compact Digital Holter Recorder and Controller (K021470)

Submission Summary (Full Text)

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## Section 2 Summary

న్న

| | 510(k) Summary of Safety and Effectiveness | MAY 1 9 2005 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date: | March 18, 2005 | |
| 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 Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] | |
| Device:<br>Trade Name: | SEER Light Extend Compact Digital Holter System | |
| Common/Usual Name: | Digital Ambulatory Holter Recorder | |
| Classification Names: | 21 CFR 870.2800 Electrocardiograph Ambulatory (without analysis) Medical<br>Magnetic Tape Recorder | |
| Predicate Device: | SEER Light Compact Digital Holter Recorder and Controller (K021470) | |
| Device Description: | The SEER Light Extend Compact Digital Holter Recorder is designed to<br>acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of<br>pediatric or adult patients for up to 48 hours. The device stores the acquired<br>ECG data in its on-board flash memory. The SEER Light Extend Controller<br>downloads patient demographic information into the SEER Light Extend<br>Compact Digital Holter Recorder and allows the user to check the signal<br>quality of the ECG data at hookup time. At the end of the recording, the SEER<br>Light Extend Controller is connected to the SEER Light Extend Compact<br>Digital Holter Recorder by a cable and the stored ECG data is transferred from<br>the recorder to the controller onto a standard compact flash memory card.<br>Alternately, the SEER Light Connect, a USB interface, can download patient<br>demographic information from a PC into the SEER Light Extend Compact<br>Digital Holter Recorder and, via a PC, allows the user to check the signal<br>quality of the ECG data at hookup time. At the end of recording, the SEER<br>Light Extend Compact Digital Holter Recorder can be connected to the SEER<br>Light Connect and the stored ECG data is transferred from the recorder<br>directly to a PC. | |
| Intended Use: | The SEER Light Extend Compact Digital Holter System is intended to acquire<br>ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and<br>adult patients. The device stores this data along with patient demographic<br>information to on board flash memory. | |
| | The SEER Light Extend Compact Digital Holter System is intended to be used<br>by trained operators under the direct supervision of a licensed healthcare<br>practitioner in a hospital or medical professional's facility. | |

The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data.

The SEER Light Extend Compact Digital Holter System is not intended for use on patients weighing less than 10Kg.

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p.2;2

- The proposed SEER Light Extend Compact Digital Holter System employs the Technology: same functional scientific technology as the predicate device SEER Light Compact Digital Holter Recorder and Controller System (K021470).
- The SEER Light Extend Compact Digital Holter Recorder and Controller Test Summary: System 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 device:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration Testing (System verification) .
- Final acceptance testing (Validation) .
- Performance testing .
- . Safety testing
- Environmental Testing .
- The results of these measurements demonstrated that the SEER Light Extend Conclusion: Compact Digital Holter System is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2005

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

Re: K050731

K050731
Trade Name: SEER Light Extend Compact Digital Holter System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: March 17, 2005 Received: March 21, 2005

Dear Ms. Baumhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(K) prematics is substantially equivalent (for the indications
referenced above and have determined the devices morketed in interstate reterenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced prodical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that ao not require to the general controls provisions of the Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Fect morado requirements of the management 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 classified (see above) mis clinity major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affec may be subject to such additional controlist. Existing may of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarders, on the Federal Register.

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Page 2 – Ms. Lisa Baumhardt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issuated of a backed on a backer requirements of the Act
that FDA has made a determination that your device complies with other mant that FDA has made a decommancis an administered by other Federal agencies. You must or any Federal statutes and regulations daminders, but not limited to: registration and listing (21 l comply with an the Act 3 requirements, n.c. and acturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and If applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 STR 1980-1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients over device as described in your Section 510(k) I his letter will anow you to begin manically your and equivalence of your device to a legally premarket nothication: The PDF mining of castion 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 If you uesire specific advice for your as not 2011-01-20120. Also, please note the regulation entitled, Colliact the Office of Compilance was (21CFR Part 807.97) you may obtain. IMISULanung by ICIEICHC to premailities under the Act may be obtained from the Oiller general mionmation on your responsional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B.Bumiman 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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K050731 510(k) Number (if known):

SEER Light Extend Compact Digital Holter System Device Name:

## Indications For Use:

The SEER Light Extend Compact Digital Holter Recorder and Controller System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric and adult patients. acquire annoulatory 2 of 5 chamic 20 C stient demographic information to on board flash memory.

The SEER Light Extend Compact Digital Holter System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.

The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data.

The SEER Light Extend Compact Digital Holter System ismot intended for use on patients weighing less than 10Kg.

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

Over-The-Counter Use (Per 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)

Blumner

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