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 Description

The SEER Light Compact Digital Holter Recorder is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface for no longer than 24 hours. The device stores the acquired ECG data in its on-board 32 megabytes of flash memory. Additionally, the SEER Light controller downloads patient demographic information into the SEER Light recorder and checks the signal quality of the ECG data at hookup time via isolated, infra-red communications. At the end of the recording the SEER Light controller is connected to the SEER Light recorder by cable and the stored ECG data is transferred to it and onto a standard compact flash memory card.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SEER Light Compact Digital Holter Recorder:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly define specific numerical acceptance criteria for performance metrics. Instead, it states that the device "complies with the voluntary standards as detailed in Section 9 of this submission" (Section 9 is not provided here) and that 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."

Therefore, the acceptance criteria are implicitly tied to meeting the performance of the predicate device (K001317 Aria Digital Holter Recorder®) and relevant voluntary standards. Specific quantitative performance data from comparative testing are not detailed in this summary.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with voluntary standards (as detailed in Section 9)	The SEER Light complies with the voluntary standards.
As safe as the predicate device (K001317 Aria Digital Holter Recorder®)	Demonstrated to be as safe as the predicate device.
As effective as the predicate device (K001317 Aria Digital Holter Recorder®)	Demonstrated to be as effective as the predicate device.
Performs as well as the predicate device (K001317 Aria Digital Holter Recorder®)	Demonstrated to perform as well as the predicate device.
Quality assurance measures applied to development (Requirements specification review, Code inspections, Software and hardware testing, Safety testing, Environmental testing, Final validation)	The listed quality assurance measures were applied to the development of the system.

Important Note: Without access to "Section 9 of this submission" and the specific test results comparing the SEER Light to the predicate device, it's impossible to provide granular numerical acceptance criteria or performance metrics specific to ECG signal quality, data storage integrity, or accuracy that would typically be expected for such a device. This summary focuses on demonstrating equivalence rather than establishing new performance benchmarks.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample size used for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It only broadly mentions "software and hardware testing," "safety testing," and "environmental testing" as part of the quality assurance measures.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided text does not mention the use of experts or the establishment of ground truth for any test set in the context of clinical performance or diagnostic accuracy, as the device states it "does not perform any analysis on the ECG data." Its function is purely for acquisition and storage.

4. Adjudication Method

Given that no experts or clinical performance evaluations involving diagnostic interpretation are mentioned, there is no adjudication method described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or is mentioned. The device, by its stated intended use, does not perform analysis on ECG data, so a study evaluating human readers' improvement with or without AI assistance would not be applicable.

6. Standalone Performance Study

The provided text does not describe a standalone (algorithm only without human-in-the-loop performance) study in the context often associated with diagnostic AI algorithms. The device itself is a standalone recorder, but its "performance" is based on its ability to acquire and store ECG signals reliably, not on its analytical capabilities. The testing mentioned (software, hardware, safety, environmental, final validation) would fall under performance testing, but not in the context of an "algorithm only" diagnostic performance study.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used for diagnostic algorithms (e.g., pathology, outcomes data, expert consensus) does not apply to this device's stated function. The device acquires ECG signals; it does not interpret them. Therefore, its "ground truth" would relate to the accuracy of the recorded signal itself (e.g., comparison to a reference ECG machine for signal fidelity, absence of artifact, proper data storage). However, the document does not elaborate on how this type of ground truth was established.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. This device is a hardware recorder, not an AI/machine learning model that typically requires a training set.

9. How the Ground Truth for the Training Set Was Established

As this is a hardware device for ECG data acquisition and not an AI/machine learning model, the concept of a "training set" and establishing "ground truth for a training set" as typically understood in AI/ML development is not applicable. The device's "performance" is validated through engineering and functional testing against specifications and standards, not through training on data with established ground truth for diagnostic purposes.

Summary

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K021470

Date:	NOV 1 4 2002
Date:	November 12, 2002
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Lisa Lee MichelsRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (262) 293-1609Fax: (414) 918-8203
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 (withoutAnalysis) MWJ
Predicate Devices:	K001317 Aria Digital Holter Recorder®
Device Description:	The SEER Light Compact Digital Holter Recorder is designed toacquire ambulatory 2 or 3 channels of ECG signal from the chestsurface for no longer than 24 hours. The device stores theacquired ECG data in its on-board 32 megabytes of flashmemory. Additionally, the SEER Light controller downloadspatient demographic information into the SEER Light recorderand checks the signal quality of the ECG data at hookup time viaisolated, infra-red communications. At the end of the recordingthe SEER Light controller is connected to the SEER Lightrecorder by cable and the stored ECG data is transferred to it andonto a standard compact flash memory card.
Intended Use:	The intended use of the SEER Light Compact Digital HolterRecorder is to acquire ambulatory 2 or 3 channels of ECG signalfrom the chest surface of pediatric or adult patients for no longerthan 24 hours. The device stores this data along with patientdemographic information to on board flash memory. It does notperform any analysis on the ECG data.The SEER Light Compact Digital Holter Recorder is intended tobe used under the direct supervision of a licensed healthcarepractitioner, by trained operators in a hospital or medicalprofessional's facility.
Technology:	The proposed SEER Light employs the same technology as thepredicate 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).