(303 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the modification as a "modified software version" to improve arrhythmia detection, without mentioning AI/ML techniques.
No
The device is described as a "Bedside Monitoring System" capable of monitoring various physiological parameters. Its intended use is for patient care provided by healthcare professionals, but it does not perform any therapeutic interventions or treatments.
Yes
Explanation: The device monitors various physiological parameters such as heart rate, respiration rate, arrhythmia, and cardiac output, which are used by healthcare professionals to assess a patient's medical condition and determine when intervention is indicated, directly supporting diagnostic processes.
No
The device description explicitly states that the hardware of the SC9000/SC9015 is unchanged, indicating it is a hardware device with updated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device monitors physiological parameters directly from the patient (heart rate, respiration rate, pressure, temperature, etc.). It does not process biological samples like blood, urine, or tissue.
- The device connects to other medical devices, not laboratory equipment. The connections mentioned are to a ventilator and a blood gas/cardiac output monitor, which are used for patient care and monitoring, not for in vitro analysis of samples.
- The parameters monitored are physiological measurements. Heart rate, respiration rate, pressure, temperature, etc., are all direct measurements of bodily functions, not analyses of substances within the body.
Therefore, this device falls under the category of a patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is capable of monitoring:
- heart rate
- respiration rate
- invasive pressure
- non-invasive pressure
- arrhythmia
- temperature
- cardiac output
- arterial oxygen saturation
- pulse rate
- cardiac output
- end-tidal carbon dioxide and (central) apnea.
This device can be connected to third party devices. Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac ourput monitor. 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 devermine 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 Noonatal populations, with the exception of the parameter Cardiac Output which is intended for use in the adult and pediaric populations only; and Arrhythmia which is intended for use in the adult population only.
Product codes
74DSI
Device Description
The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC900/ SC9015 Bedside Monitoring System. The modification improves the detection and monitoring of arrhythmia. The hardware of the SC9000/SC9015 is unchanged.
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 which is intended for use in the adult and pediaric populations only; and Arrhythmia which is intended for use in the adult 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 devermine 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Monitor with modified arrhythmia detection complies with:
AAMI (ECAR - D-94) " Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' March 1994.
AAMI (EC13 - 1992) "Cardiac monitors, heart rate meters, and alarms".
FDA "Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)".
Clinical performance is equal to, or surpasses that of the predicate device. The assessment of clinical performance is attached in appendix V.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
SEP | | 1997
510(k) SUMMARY as required per 807.92(c)
2: Submitter's Name, Address:
Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: Robert W. Becker Contact person for this submission: Jacqueline E. M. Emery or Fred Geheb Date submission was prepared: October 24, 1996
3: Trade Name, Common Name and Classification Name:
A. Trade Name: Siemens SC9000/ SC9015 Bedside Monitoring System
B. Common Name, Classification Number, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Cardiac monitor | 74DRT | II | 21 CFR 870.2300 |
| Arrhythmia detector | |||
| & Alarm System | 74DSI | III | 21 CFR 870.1025 |
| Breathing frequency | |||
| monitor | 73BZQ | II | 21 CFR 868.2375 |
| Pulse rate monitor | 74BWS | II | 21 CFR 870.2300 |
| Non-indwelling blood | |||
| pressure monitor | 74DXN | II | 21 CFR 870.1130 |
| Clinical electronic thermometer | 80BWX | II | 21 CFR 880.2910 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Cardiac Output Monitor | 74KFN | II | 21 CFR 870.1435 |
| end-tidal Carbon-Dioxide Monitor | 73CCK | II | 21 CFR 868.1400 |
| Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 |
| 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 |
- Pending FDA clearance of 510(K) K962291
Siemens Medical Systems, Inc.
Electromedical Group
1
4: Predicate Device Identification:
The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC9000/SC9015 Bedside Monitoring System. The hardware of the SC9000/SC9015 is unchanged. The modification improves the detection and monitoring of arrhythmia. The Siemens SC9000/SC9015 Bedside Monitoring Systems was granted 510(K) clearance under the following 510(K) numbers:
K946306 - Siemens SC9000/SC9015 Monitor (Original Submission) K954632 - Siemens SC9000/SC9015 Monitor with etCO2 Functionality
The following submission is currently awaiting FDA 510(K) clearance:
K962291 - Siemens SC9000/SC9015 Monitor modified with Neonatal Functionality.
5. Device Description
The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC900/ SC9015 Bedside Monitoring System. The modification improves the detection and monitoring of arrhythmia. The hardware of the SC9000/SC9015 is unchanged.
6. Intended Use:
The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia (adult), temperature, cardiac output, arterial oxygen saturation, pulse rate, cardiac output, end-tidal carbon dioxide and (central) apnea. This device will produce visual and aural alarms if any of these parameters vary bevond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity(Olympus)network.
The SC9000/SC9015 Modified Patient Monitoring System is intended to be used on Adult. Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediatric populations only, and Arrhythmia, which is intended for use in the adult population only.
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
2
7. Table of device similarities and differences to predicate device
ﺴﺴﺴﺴ
| | Modified Algorithm | Predicate
Device
Algorithm | Explanation of the modified
version |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | Siemens Medical Systems EMG | same | |
| Device name | SC9000 with modified
arrhythmia algorithm | SC9000 | 2 leads improve arrhythmia
detection |
| 510(K) Number | To be assigned | K946306 | |
| Intended Population | Adult, pediatric and neonatal * | same | Same-application areas.
Arrhythmia detection is inactive in
the neonatal mode. |
| Software Revision | VB1.1-W | VA2-W | |
| Display: | up to 2 leads | same | |
| Available leads: | I, II, III, aVR, aVF, aVL, V,
MCL1, MCL6
(MCL1, MCL6 only with 3-lead
set;
V, aVR, aVF, aVL only with 5
lead set) | same | |
| Measuring range: | 15 - 300 bpm | same | |
| Accuracy: | ±5 bpm /min. or ± 5%
(whichever is greater) | same | |
| QRS detection:
amplitude:
duration: | 0.5 - 5.0 mV
40-120 msec | same
70 - 120 msec | extended to 40 for neonatal. |
| Frequency ranges:
filter setting = | 0.5 to 40 Hz | same | |
| Monitor:
filter setting = ESU: | 0.5 to 20 Hz | same | |
| filter setting = Off: | 0.05 to 40 Hz | same | |
| Degree of protection
against electrical shock | Type CF | same | |
| Defibrillation protection | In accordance with IEC 6-1-2-27 | same | |
| Arrhythmia Detection: | Yes | same | |
| Pacer Detection: | Yes | same | |
| Samples/Sec | 250 Samples/Second | 100
Samples/Sec | Increased sample rate for
improved QRS processing. |
- with the exception of the parameter Cardiac Output, which is intended for use in the adult and pediations only, and Arrhythmia, which is intended for use in the adult population only.
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
3
8. Assessment of non-clinical performance data for equivalence:
Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Monitor with modified arrhythmia detection complies with:
AAMI (ECAR - D-94) " Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' March 1994.
AAMI (EC13 - 1992) "Cardiac monitors, heart rate meters, and alarms".
FDA "Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)".
9. Assessment of clinical performance data for equivalence:
Clinical performance is equal to, or surpasses that of the predicate device. The assessment of clinical performance is attached in appendix V.
-
Bio-compatabilityData: Not applicable
-
Sterilization data: Not applicable
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
4
Image /page/4/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 1 1 1997
Ms. Jacqueline E.M. Emery Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923
K964624 Re: Siemens SC9000/SC9015 Bedside Monitoring System with Modified Arrhythmia Monitoring Regulatory Class: III (three) Product Code: 74 DSI March 8, 1997 Dated: Received: June 10, 1997
Dear Ms. Emery:
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, 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.
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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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.
5
Page 2 - Ms. Jacqueline E.M. Emery
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. Cillehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: Device De Siemens SC9000/SC9015 Bedside Monitoring System with Modified Arrhythmia Monitoring
Indications for Use:
This device is capable of monitoring:
- � heart rate
- respiration rate ●
- . invasive pressure
- non-invasive pressure ●
- arrhythmia .
- . temperature
- � cardiac output
- . arterial oxygen saturation
- . pulse rate
- . cardiac output
- end-tidal carbon dioxide and (central) apnea .
This device can be connected to third party devices. Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac ourput monitor. 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 devermine 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 Noonatal populations, with the exception of the parameter Cardiac Output which is intended for use in the adult and pediaric populations only; and Arrhythmia which is intended for use in the adult population only.
MRI Compatibility Statement:
The Siemens SC9000/SC9015 Series is not compatible for use in an 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) |
(Division Sign-Off)
Division of Cardiovascular, Respiratory,and Neurological Devices
510(k) Number __