(59 days)
No
The document explicitly states "The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data." and there are no mentions of AI, DNN, or ML.
No
The device is a Holter Recorder and Controller System, which is used to acquire and store ECG signals for diagnostic purposes, not to treat a condition.
Yes
Explanation: The device is described as acquiring ambulatory ECG signals from the chest surface of patients, and it stores this data. While it explicitly states that it "does not perform any analysis of the ECG data," the act of collecting and storing physiological data for later review by a healthcare practitioner for the purpose of understanding a patient's condition falls under the umbrella of diagnostic activities. The data collected is intended to provide information that can lead to a diagnosis.
No
The device description explicitly mentions a "SEER Light Extend Compact Digital Holter Recorder" which is a hardware component designed to acquire and store ECG signals. It also mentions a "SEER Light Extend Controller" and a "SEER Light Connect, a USB interface," which are also hardware components used for data transfer and interaction with the recorder. Therefore, the system includes significant hardware elements and is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The SEER Light Extend Compact Digital Holter Recorder and Controller System acquires ECG signals directly from the chest surface of a patient. This is a non-invasive measurement taken from the body, not a test performed on a sample from the body.
- Intended Use: The intended use is to acquire and store ECG data, not to analyze biological samples for diagnostic purposes.
- Lack of Sample Analysis: The description explicitly states that the device "does not perform any analysis of the ECG data." IVDs are inherently involved in the analysis of biological samples.
Therefore, the SEER Light Extend Compact Digital Holter Recorder and Controller System is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
MWJ
Device Description
The SEER Light Extend Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data in its on-board flash memory. The SEER Light Extend Controller downloads patient demographic information into the SEER Light Extend Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of the recording, the SEER Light Extend Controller is connected to the SEER Light Extend Compact Digital Holter Recorder by a cable and the stored ECG data is transferred from the recorder to the controller onto a standard compact flash memory card. Alternately, the SEER Light Connect, a USB interface, can download patient demographic information from a PC into the SEER Light Extend Compact Digital Holter Recorder and, via a PC, allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the SEER Light Extend Compact Digital Holter Recorder can be connected to the SEER Light Connect and the stored ECG data is transferred from the recorder directly to a PC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest surface
Indicated Patient Age Range
pediatric and adult patients.
The SEER Light Extend Compact Digital Holter System is not intended for use on patients weighing less than 10Kg.
Intended User / Care Setting
trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 | |
| 8200 West Tower Avenue | ||
| Milwaukee, WI 53223 | ||
| USA | ||
| Contact Person: | Lisa M. Baumhardt | |
| Regulatory Affairs Specialist | ||
| GE Medical Systems Information Technologies | ||
| Phone: (262) 293-1699 | ||
| Fax: (262) 293-1460 | ||
| Device: | ||
| 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 | |
| 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 | |
| acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of | ||
| pediatric or adult patients for up to 48 hours. The device stores the acquired | ||
| ECG data in its on-board flash memory. The SEER Light Extend Controller | ||
| downloads patient demographic information into the SEER Light Extend | ||
| Compact Digital Holter Recorder and allows the user to check the signal | ||
| quality of the ECG data at hookup time. At the end of the recording, the SEER | ||
| Light Extend Controller is connected to the SEER Light Extend Compact | ||
| Digital Holter Recorder by a cable and the stored ECG data is transferred from | ||
| the recorder to the controller onto a standard compact flash memory card. | ||
| Alternately, the SEER Light Connect, a USB interface, can download patient | ||
| demographic information from a PC into the SEER Light Extend Compact | ||
| Digital Holter Recorder and, via a PC, allows the user to check the signal | ||
| quality of the ECG data at hookup time. At the end of recording, the SEER | ||
| Light Extend Compact Digital Holter Recorder can be connected to the SEER | ||
| Light Connect and the stored ECG data is transferred from the recorder | ||
| directly to a PC. | ||
| 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. |
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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
510ik) N