(25 days)
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No
The document does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard physiological monitoring parameters.
No
The device is described as a monitor that measures various physiological parameters, which is indicative of a diagnostic or monitoring device, not a device that provides therapy or treatment.
Yes
The device monitors various physiological parameters such as heart rate, respiration rate, blood pressure, temperature, cardiac output, arrhythmia, and gas concentrations, which are all used to assess a patient's medical condition and aid in diagnosis.
No
The device description explicitly states "Siemens SC 8000 Bedside Monitor," which is a hardware device. The description also mentions "MultiGas™ and MultiGas+™ modules," which are hardware components. The device monitors various physiological parameters, which requires hardware sensors and processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The SC 8000 Bedside Monitor directly monitors physiological parameters of the patient (heart rate, respiration, pressure, oxygen saturation, gas concentrations, etc.) It does not analyze samples taken from the patient.
The device is a patient monitoring system used in a clinical setting to provide real-time physiological data about the patient's condition. This falls under the category of patient monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SC 8000 Bedside monitor with Advanced Communication Option is capable of monitoring:
- Heart rate .
- . Respiration rate
- Invasive pressure .
- Non-invasive pressure ●
- Arrhythmia .
- Temperature
- Cardiac output
- Arterial oxygen saturation ●
- Pulse rate .
- (central) apnea
- . ST Segment Analysis
- . 12-Lead ST Segment Analysis
With the MultiGas™ and MultiGas+™ modules the SC8000 is capable of measuring: - Respiration rate
- . Inspired and expired Carbon Dioxide (CO2)
- Inspired and expired Oxygen (MultiGas+TM only) .
- . Average inspired Oxygen (MultiGasTM only)
- Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Sevoflurane, . and Nitrous Oxide.
The SC 8000 Bedside Monitor can interface with third party devices.
Product codes (comma separated list FDA assigned to the subject device)
MXH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
Intended User / Care Setting
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 25 1999
Mr. David Simard Quality Assurance and Requlatory Affairs Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
Re : K990563 Siemens SC 8000 Bedside Monitor with Advanced Communication Option Regulatory Class: III (three) Product Code: MXH Dated: February 19, 1999 February 22, 1999 Received:
Dear Mr. Simard:
This letter corrects our substantially equivalent letter of March 19, 1999, regarding the enclosure to the letter. We erroneously enclosed the Intended Use Statement in place of the Indications for Use Statement.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to leqally 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). 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.
1
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number (if known):_
Siemens SC 8000 Bedside Monitor with Advanced Communication Option Device Name:
Indications for Use:
The SC 8000 Bedside monitor with Advanced Communication Option is capable of monitoring:
- Heart rate .
- . Respiration rate
- Invasive pressure .
- Non-invasive pressure ●
- Arrhythmia .
- Temperature
- Cardiac output
- Arterial oxygen saturation ●
- Pulse rate .
- (central) apnea
- . ST Segment Analysis
- . 12-Lead ST Segment Analysis
With the MultiGas™ and MultiGas+™ modules the SC8000 is capable of measuring:
- Respiration rate
- . Inspired and expired Carbon Dioxide (CO2)
- Inspired and expired Oxygen (MultiGas+TM only) .
- . Average inspired Oxygen (MultiGasTM only)
- Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Sevoflurane, . and Nitrous Oxide.
The SC 8000 Bedside Monitor can interface with third party devices.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibility Statement:
The Siemens SC 8000 Bedside Monitor is not compatible for use in a MRI magnetic field.
(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
Cardiovascular R and Neurological Devices 510(k) Number