(22 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware modifications and standard physiological monitoring parameters.
No
The device is described as a "bedside monitor" capable of monitoring various physiological parameters. Its intended use is for "patient care" by "Healthcare Professionals," and it does not mention directly providing therapy or treatment.
No
The device is a bedside monitor that measures various physiological parameters. While these measurements can inform a diagnosis, the device itself gathers data rather than providing a diagnostic conclusion. Its use is determined by healthcare professionals based on their assessment of the patient's condition, suggesting it provides data for their diagnostic process, not the diagnosis itself.
No
The device description explicitly states it is a "bedside monitor" and describes hardware components ("hardware has been reengineered as a unit without a display"). While it supports software options, it is fundamentally a hardware device with integrated software.
Based on the provided information, the SC 8000 Bedside monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SC 8000 Function: The SC 8000 Bedside monitor is described as a device that monitors various physiological parameters directly from the patient (e.g., heart rate, respiration rate, blood pressure, oxygen saturation). It does not process samples taken from the body in a laboratory setting.
- Intended Use: The intended use clearly states it's for monitoring patients in a healthcare setting by professionals, not for analyzing biological samples.
Therefore, the SC 8000 Bedside monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the SC 8000 Bedside Monitor is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, (central) apnea, cardiac output, ST Segment Analysis, 12-lead ST Segment Analysis, and transcutaneous partial pressure of oxygen and transcutaneous carbon dioxide. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to a Siemens R50 Bedside recorder, either directly or via the Infinity Network.
Product codes
74DRT, 74BWS, 74DQA, 73BZQ, 80BWX, 74CAA, 74FLO, 73FLS, 74FLP, 74DSI, 74DXJ, 74MLD, 74DXN, 73LKD, 73KLK
Device Description
The SC 8000 bedside monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors (K982730). The SC 8000 supports all SC 7000 software based options and offers all of the standard I/O connections of the SC 7000 plus interface plate. The hardware has been reengineered as a unit without a display that allows customers the option of providing their own medical-grade display.
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 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/CO2 which is to be used in the neonatal population only.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Assessment of non-clinical performance data for equivalence: See Section L
Assessment of clinical performance data for equivalence: Not applicable
Key Metrics
Not Found
Predicate Device(s)
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
510(k) SUMMARY
6 1998 NOW
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: October 9, 1998
Trade Name, Common Name and Classification Name:
A. Trade Name: Siemens SC 8000 Bedside Monitor
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification
Number | Class | Regulation Number |
|----------------------------------------------------------------|--------------------------|-------|-------------------|
| Cardiac monitor | 74DRT | II | 21 CFR 870.2300 |
| Pulse rate monitor | 74BWS | II | 21 CFR 870.2300 |
| Pulse oximeter | 74DQA | II | 21 CFR 870.2700 |
| Breathing Frequency Monitor | 73BZQ | II | 21 CFR 868.2375 |
| Clinical Electronic Thermometer | 80BWX | II | 21 CFR 880.2910 |
| Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 |
| Heart Rate Monitor, Neonatal | 74FLO | II | 21 CFR 870.2300 |
| Ventilatory Effort Monitor (Apnea Detector) | 73FLS | II | 21 CFR 868.2375 |
| Monitor Blood Pressure, Neonatal, Invasive | 74FLP | II | 21 CFR 870.1110 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |
| Medical Cathode-Ray Tube Display | 74DXJ | II | 21 CFR 870.2450 |
| ST Segment Monitor with Alarm | 74MLD | III | 21 CFR 870.1025 |
| Non-indwelling Blood Pressure Monitor | 74DXN | II | 21 CFR 870.1130 |
| Monitor, Carbon-Dioxide, Cutaneous | 73LKD | II | 21 CFR 868.2480 |
| Monitor, Oxygen, Cutaneous, for infant not under gasanesthesia | 73KLK | II | 21 CFR 868.2500 |
Legally Marketed Device Identification:
Siemens SC 7000/SC9000 XL INFINITY Modular Bedside Monitors, 510(k) submission K982730.
l
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
1
Description of Modification:
The SC 8000 bedside monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors (K982730). The SC 8000 supports all SC 7000 software based options and offers all of the standard I/O connections of the SC 7000 plus interface plate. The hardware has been reengineered as a unit without a display that allows customers the option of providing their own medical-grade display.
Intended Use:
The intended use of the SC 8000 Bedside Monitor is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation, pulse rate, (central) apnea, cardiac output, ST Segment Analysis, 12-lead ST Segment Analysis, and transcutaneous partial pressure of oxygen and transcutaneous carbon dioxide. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to a Siemens R50 Bedside recorder, either directly or via the Infinity Network.
Assessment of non-clinical performance data for equivalence: See Section L
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: See Declaration of Conformity, Section P-1
2
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (978) 907-7500 Fax: (978) 750-6879 Telex: 511958 (Siemensm SD)
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923
K983632 Re : Siemens SC 8000 Bedside Monitor Trade Name: Requlatory Class: III Product Code: 74 DSI Dated: October 14, 1998 Received: October 15, 1998
Dear Ms. Greco:
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 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, Druq, 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, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, 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.
3
Page 2 - Ms. Penelope H. Greco
This letter will allow you to begin 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 labeling 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (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, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_
Device Name:
Indications for Use:
The SC 8000 Bedside monitor 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 ●
- tcpO2/CO2 .
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/CO2 which is to be used in the neonatal population only.
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_
(Optional Format 1-2-96)
N. Deelutelli
sion Sion-Off Division of Cardiovascular, Respiratory, and Neurological Devi 510(k) Number