(194 days)
No
The document describes a standard physiological patient monitoring system and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is described as a "multiparameter physiological patient monitoring system," which indicates it is used for monitoring, not for delivering therapy.
No
Explanation: The device is a multiparameter physiological patient monitoring system, which collects and displays physiological data. It is not described as diagnosing specific conditions or diseases.
No
The device description explicitly lists multiple hardware components including a processing unit, display, acquisition modules, keypad, and optional components like a central station and printers. This indicates it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, the Solar 8000M System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "multiparameter physiological patient monitoring." It measures physiological parameters directly from the patient (e.g., ECG, blood pressure, pulse, temperature, etc.).
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. The Solar 8000M System does not analyze such specimens.
- Device Description: The components described are typical of a patient monitoring system, not an IVD device.
- Lack of Specimen Analysis: There is no mention of analyzing biological specimens in the intended use or device description.
Therefore, the Solar 8000M System falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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™ network.
The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.
Product codes
MHX
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
licensed healthcare practitioner or by personnel trained in the use of the equipment. within a hospital or facility environment.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K993757 Solar 7/8000 System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB 1 1 2002
Section 2 Summary and Certification
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | July 31, 2001 |
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Karen Webb |
| Sr. Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 362-3329 | |
| Fax: (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 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 |
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.
1
2/2
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.
2
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
3
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
4
Page 1 of 1
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)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012467