SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

K021470 · General Electric Medical Systems Information Techn · MWJ · Nov 14, 2002 · Cardiovascular

Device Facts

• Record ID: K021470
• Device Name: SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
• Applicant: General Electric Medical Systems Information Techn
• Product Code: MWJ · Cardiovascular
• Decision Date: Nov 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data. The SEER Light Compact Digital Holter Recorder is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Device Story

SEER Light Compact Digital Holter Recorder acquires 2 or 3 channels of ECG signals from chest surface; stores data and patient demographics on 32MB on-board flash memory. Controller downloads patient info to recorder and verifies signal quality via isolated infra-red link at hookup. Post-recording, controller connects via cable to transfer data to standard compact flash memory card. Used in hospitals or medical facilities by trained operators under licensed practitioner supervision. Device performs no analysis; provides raw data for subsequent review.

Clinical Evidence

Bench testing only. No clinical data provided. Quality assurance measures included requirements specification review, code inspections, software/hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

Ambulatory 2 or 3-channel ECG recorder; 32MB on-board flash memory; infra-red communication for hookup; cable-based data transfer to compact flash card. No on-board ECG analysis. Complies with voluntary standards.

Indications for Use

Indicated for pediatric and adult patients requiring ambulatory 2 or 3-channel ECG monitoring for up to 24 hours.

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

• Aria Digital Holter Recorder (K001317)

Submission Summary (Full Text)

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# K021470

| Date: | NOV 1 4 2002 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 12, 2002 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Lisa Lee Michels<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: Trade Name: | SEER Light Compact Digital Holter Recorder or (SEER Light) |
| Common/Usual Name: | Digital Ambulatory Monitor |
| Classification Names: | 21 CFR 870.2800 Electrocardiograph, Ambulatory (without<br>Analysis) MWJ |
| Predicate Devices: | K001317 Aria Digital Holter Recorder® |
| Device Description: | The SEER Light Compact Digital Holter Recorder is designed to<br>acquire ambulatory 2 or 3 channels of ECG signal from the chest<br>surface for no longer than 24 hours. The device stores the<br>acquired ECG data in its on-board 32 megabytes of flash<br>memory. Additionally, the SEER Light controller downloads<br>patient demographic information into the SEER Light recorder<br>and checks the signal quality of the ECG data at hookup time via<br>isolated, infra-red communications. At the end of the recording<br>the SEER Light controller is connected to the SEER Light<br>recorder by cable and the stored ECG data is transferred to it and<br>onto a standard compact flash memory card. |
| Intended Use: | The intended use of the SEER Light Compact Digital Holter<br>Recorder is to acquire ambulatory 2 or 3 channels of ECG signal<br>from the chest surface of pediatric or adult patients for no longer<br>than 24 hours. The device stores this data along with patient<br>demographic information to on board flash memory. It does not<br>perform any analysis on the ECG data.<br>The SEER Light Compact Digital Holter Recorder is intended to<br>be used under the direct supervision of a licensed healthcare<br>practitioner, by trained operators in a hospital or medical<br>professional's facility. |
| Technology: | The proposed SEER Light employs the same technology as the<br>predicate device. |

# 510(k) Summary of Safety and Effectiveness

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# Test Summary:

The SEER Light 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:

- Requirements specification review .
- Code inspections ●
- Software and hardware testing ●
- Safety testing ●
- Environmental testing .
- Final validation .

# Conclusion:

The results of these measurements demonstrated that the SEER Light Compact Digital Holter Recorder is as safe, as effective, and performs as well as the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Lisa Lee Michels Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K021470

Trade Name: SEER Light Compact Digital Holter Recorder and Controller Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: August 23, 2002 Received: August 26, 2002

# Dear Ms. Michels:

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 such 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.

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## Page 2 - Ms. Lisa Lee Michels

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); 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. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Elio Mallis

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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5 10(k) Number (if known):

1021470

Device Name:

SEER Light Compact Digital Holter Recorder

#### Indications For Use:

The intended use of the SEER Light Compact Digital Holter Recorder is to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for no longer than 24 hours. The device stores this data along with patient demographic information to on board flash memory. It does not perform any analysis on the ECG data.

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

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021470
Elias Mallis

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)