The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices. The Solar 8000M System is also intended to provide physiologic data over the UNITY Tu network. The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Device Description

The Solar 8000M System includes the following basic components: Solar 8000M processing unit a display TRAM-rac housing acquisition module(s) keypad and/or remote control Additional, optional components include: Clinical Information Center (central station) Remote display digital writer or printer TRAM-Net interface adapter(s) Octanet connectivity device Remote Alarm Box

AI/ML Overview

This submission describes a patient monitoring system and does not contain detailed performance metrics or specific acceptance criteria in the format typically seen for algorithm-based devices. Therefore, I cannot extract all the requested information for acceptance criteria and a study that proves the device meets them.

However, I can provide information based on the available text:

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported device performance values. The "Test Summary" only lists the types of tests performed.

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

The document does not specify a sample size for any "test set" in the context of an algorithm's performance. It mentions "Clinical use validation" but provides no details on the number of patients, data origin, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided. The submission focuses on hardware and system functionality, not algorithmic interpretation requiring expert ground truth.

4. Adjudication Method:

This information is not provided.

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

No MRMC study is mentioned. This submission is about a patient monitoring system, not an AI-assisted diagnostic tool.

6. Standalone Performance:

The document does not describe standalone (algorithm-only) performance in the sense of a diagnostic algorithm without human intervention. The device's function is to display and store physiological data for healthcare practitioners.

7. Type of Ground Truth Used:

The concept of "ground truth" as it applies to diagnostic algorithms (e.g., pathology, expert consensus) is not relevant to this submission. The "ground truth" for a patient monitor would be the actual physiological readings, which are measured directly by the device's sensors. The document states "performance testing" was done, implying comparison against expected physiological values or established calibration standards for each parameter monitored.

8. Sample Size for the Training Set:

This information is not applicable. The device described is a physiological patient monitor, not an AI/ML algorithm that undergoes a "training set."

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

This information is not applicable, as there is no training set for an AI/ML algorithm.

Summary of available information related to performance and testing:

Acceptance Criteria (Implicit and general, not specific metrics):

Safety: The device is as safe as the predicate device.
Effectiveness: The device is as effective as the predicate device.
Performance: The device performs as well as the predicate device.
Compliance: The device complies with voluntary standards.
Functionality: Adherence to requirements (via requirements reviews, design reviews, unit, integration, and final acceptance testing).
Environmental Robustness: Successful environmental testing.

Study/Testing Information:

The document mentions a "Test Summary" with the following quality assurance measures and testing:

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
Clinical use validation

Conclusion from the Submission:

"The results of these measurements demonstrated that the Solar 8000M System are as safe, as effective, and perform as well as the predicate device."

Predicate Device: K993757 Solar 7/8000 System

In essence, this 510(k) submission establishes substantial equivalence to a predicate device based on similar technology and comprehensive quality assurance testing, rather than an AI-specific performance study with detailed acceptance criteria and ground truth analysis.

Summary

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FEB 1 1 2002

Section 2 Summary and Certification

K012467

	510(k) Summary of Safety and Effectiveness
Date:	July 31, 2001
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Karen WebbSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (414) 362-3329Fax: (414) 918-8114
Device:
Trade Name:	Solar 8000M System
Common/Usual Name:	Physiological Patient Monitor
Classification Names:	Physiological Patient Monitor
Predicate Devices:	K993757 Solar 7/8000 System
Device Description:	The Solar 8000M System includes the following basic components:Solar 8000M processing unit a display TRAM-rac housing acquisition module(s) keypad and/or remote control Additional, optional components include: Clinical Information Center (central station) Remote display digital writer or printer TRAM-Net interface adapter(s) Octanet connectivity device Remote Alarm Box
Intended Use:	The Solar 8000M System is intended for use under the directsupervision of a licensed healthcare practitioner or by personnel trainedin the use of the equipment. The Solar 8000M is a multiparameterphysiological patient monitoring system intended for use on adult,pediatric and neonatal patients, within a hospital or facility environment.The Solar 8000M System is capable of monitoring electrocardiogram

n, non-invasive pressure, pulse, invasive blood pressure, blood temperature, cardiac output, respiration, pulse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices.

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K012467

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The Solar 8000M System is also intended to provide physiologic data over the UNITY Tu network.

The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Technology:

The Solar 8000M System employs the same functional scientific technology as its predicate devices.

Test Summary:

The Solar 8000M System and its host patient monitoring system comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Solar 8000M System:

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
Clinical use validation .

Conclusion:

The results of these measurements demonstrated that the Solar 8000M System are as safe, as effective, and perform as well as the predicate device.

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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 circular arrangement of text surrounding a stylized emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular fashion. The emblem in the center features a symbol that resembles three stylized human profiles or abstract shapes, arranged in a way that suggests movement or flow.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Ms. Karen M. Webb Senior Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223

Re: K012467

Trade Name: Solar 8000M System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: November 9, 2001 Received: November 13, 2001

Dear Ms. Webb:

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.

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

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Page 2 - Ms. Karen M. Webb

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Aus. R. D. Zeller, M.D.

am D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012467; 510(k) filed on July 31, 2001 510(k) Number (if known):

Solar 8000M System Device Name:

Indications for Use:

The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare The Solar Books System is meet in the use of the equipment. The Solar 8000M is a practilioner of Dy personnel trained in their system intended for use on adult, pediatio and neonatal patients, within a hospital or facility environment.

The Solar 8000M System is capable of monitoring electrocardiogram, invasive blood pressure, The Schall blood pressure, pulse, temperature, cardiac output, respiration, pdlse oximetry, venous O2 saturation, Transcutaneous O2 and CO2 respiratory mechanics, and/or (for adult and/or pediatic patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O2 and CO2 concentrations are available for electroencephalography and the can be displayed, trended and stored in the monitor from a variety of peripheral devices.

The Solar 8000M System is also intended to provide physiologic data over the UNITY™ network.

The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012467

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.