(59 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the SEER Light Extend Compact Digital Holter System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio). Instead, it relies on demonstrating equivalence to a predicate device and compliance with general quality measures.
Therefore, the "acceptance criteria" can be inferred from the overall claim of safety, effectiveness, and performance being "as well as the predicate device" and compliance with voluntary standards.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device (SEER Light Compact Digital Holter Recorder and Controller System K021470) in terms of Safety, Effectiveness, and Performance | "The results of these measurements demonstrated that the SEER Light Extend Compact Digital Holter System is as safe, as effective, and performs as well as the predicate device." |
| Compliance with Voluntary Standards | "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." (Specific standards are not detailed in the provided text.) |
| Functional Scientific Technology Equivalence | "The proposed SEER Light Extend Compact Digital Holter System employs the same functional scientific technology as the predicate device SEER Light Compact Digital Holter Recorder and Controller System (K021470)." |
| Quality Assurance Measures | Application of: 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. |
| Intended Use Fulfillment | "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 device description confirms it meets these capabilities). |
| No ECG Data Analysis Performed (for the device itself) | "The SEER Light Extend Compact Digital Holter System does not perform any analysis of the ECG data." (Explicitly stated). |
| Not for use on patients weighing less than 10Kg | "The SEER Light Extend Compact Digital Holter System is not intended for use on patients weighing less than 10Kg." (Explicitly stated). |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Test Summary" lists various testing stages (unit level, integration, final acceptance, performance, safety, environmental) but does not provide details about the data used for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not mention the use of experts to establish ground truth or their qualifications. Given that the device is a data acquisition system that does not perform any analysis of ECG data, it is unlikely that clinical ground truth (e.g., disease diagnosis) would be directly established for the device's testing. The focus of the "ground truth" would likely be on the accuracy and integrity of ECG signal acquisition and storage.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not done. The device is a "Digital Ambulatory Holter Recorder" for ECG signal acquisition. It "does not perform any analysis of the ECG data." Therefore, there is no AI component or analysis capability for human readers to interact with or be assisted by.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study for an algorithm was not applicable and therefore not done. As stated, the device "does not perform any analysis of the ECG data," implying no embedded algorithms for data interpretation or diagnosis. Its function is solely to acquire and store raw ECG data.
7. The Type of Ground Truth Used
The provided text does not explicitly state the type of ground truth used. Given the nature of the device (ECG data acquisition and storage), the "ground truth" for its testing would primarily revolve around:
- Accuracy of ECG signal acquisition: Comparing the acquired digital signal to known input signals or reference recordings.
- Integrity of data storage: Verifying that the stored data is identical to the acquired data.
- Functionality of controls and data transfer: Ensuring all features operate as designed.
It would not involve clinical ground truth like "expert consensus," "pathology," or "outcomes data" directly related to disease diagnosis, as the device does not perform analysis.
8. The Sample Size for the Training Set
The provided text does not mention a training set sample size. This type of device, which acquires and stores raw data without performing analysis, typically does not utilize a "training set" in the machine learning sense. Its development and verification would involve engineering testing and validation against specifications, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or applicable for this type of device, the method for establishing its ground truth is not discussed.
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Section 2 Summary
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| 510(k) Summary of Safety and Effectiveness | MAY 1 9 2005 | |
|---|---|---|
| Date: | March 18, 2005 | |
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223USA | |
| Contact Person: | Lisa M. BaumhardtRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (262) 293-1699Fax: (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) MedicalMagnetic 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 toacquire ambulatory 2 or 3 channels of ECG signal from the chest surface ofpediatric or adult patients for up to 48 hours. The device stores the acquiredECG data in its on-board flash memory. The SEER Light Extend Controllerdownloads patient demographic information into the SEER Light ExtendCompact Digital Holter Recorder and allows the user to check the signalquality of the ECG data at hookup time. At the end of the recording, the SEERLight Extend Controller is connected to the SEER Light Extend CompactDigital Holter Recorder by a cable and the stored ECG data is transferred fromthe recorder to the controller onto a standard compact flash memory card.Alternately, the SEER Light Connect, a USB interface, can download patientdemographic information from a PC into the SEER Light Extend CompactDigital Holter Recorder and, via a PC, allows the user to check the signalquality of the ECG data at hookup time. At the end of recording, the SEERLight Extend Compact Digital Holter Recorder can be connected to the SEERLight Connect and the stored ECG data is transferred from the recorderdirectly to a PC. | |
| Intended Use: | The SEER Light Extend Compact Digital Holter System is intended to acquireambulatory 2 or 3 channel ECG signals from the chest surface of pediatric andadult patients. The device stores this data along with patient demographicinformation to on board flash memory. | |
| The SEER Light Extend Compact Digital Holter System is intended to be usedby trained operators under the direct supervision of a licensed healthcarepractitioner 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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405073
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 (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
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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
510ik) N
§ 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).