(22 days)
No
The document describes a multi-parameter patient monitor and its communication options. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on standard physiological monitoring and data communication protocols.
No.
The device is a multi-parameter patient monitor that measures and displays various physiological parameters, but it does not provide any therapy or treatment.
Yes
Explanation: The device is explicitly described as a "multi-parameter patient monitoring" system that "monitors" various physiological parameters and produces "alarm recordings" when parameters "vary beyond preset limits." This function of observing and detecting deviations in bodily functions to inform medical decisions aligns with the definition of a diagnostic device, even if it doesn't offer a final diagnosis.
No
The device description explicitly mentions hardware components like RJ45 connectors and interfaces with external hardware modules (MultiGas, MultiGas+, MIB Protocol Converters). The intended use also describes a "monitor" which is typically a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The INFINITY SC 8000 monitor is a patient monitoring device that directly measures physiological parameters from the patient's body (heart rate, respiration, pressure, temperature, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "multi-parameter patient monitoring," which involves observing and measuring the patient's vital signs and other physiological data in real-time.
The device's function and intended use align with a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INFINITY SC 8000 monitor is intended for multi-parameter patient monitoring. The device will r no INT I 1 1 50 0000 months if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.
The INFINITY SC 8000 Monitor is capable of monitoring:
- Heart rate ●
- Respiration rate .
- Invasive pressure ●
- Non-invasive pressure .
- Arrhythmia ◆
- . Temperature
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis .
- 12-Lead ST Segment Analysis .
- tcpO2/tcpCO2 .
- EEG signals .
- FiO2 ●
With the MultiGas and MultiGas+ modules the monitor is capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.
With etCO2 the monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode
With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.
The monitor can interface with specific third party devices via an MIB protocol converter.
Product codes
MHX, 74DSI
Device Description
The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it The SC 6000 Authuned Communication of can process and display, from external devices:
MultiGas and MultiGas+ modules (K965062) Surgical Display Controller (K970348) Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248, and K010640)
A modification has been implemented in the SC 8000 Advanced Communication Option II to accommodate RJ45 connectors for interfacing to the MIB II Protocol Converter (K010640). The MIB II Protocol Converter supports the new IEEE 1073.3.2-2000, Standard for Medical Communications -Transport Profile - irDA Based - Cable Connected.
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 parameler Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediarric populations only; Arrhythmia which is not intended for use in neonatal mode; 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
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: Section J
Assessment of clinical performance data for equivalence: Not applicable
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K965062, K970348, K970368, K973222, K99166, K003248, K010640
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
as required per 807.92(c)
Submitters Name, Address:
JUL 2 0 2001
P. 1/2
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: June 26, 2001
Trade Name, Common Name and Classification Name:
A. Trade Name:
i
Siemens Medical Information Bus (MIB II) Protocol Converter Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Monitor, Physiological, Patient (with arrhythmia detection or alarms) | MHX | III | 21 CFR 870.1025 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |
Legally Marketed Device Identification:
Siemens SC 8000 K983632 SC 8000 w/Advanced Communication Option, K990563 Siemens INFINITY MIB II Protocol Converter, K010640
Description of Modification:
The SC 8000 Advanced Communication Option II is equivalent to that submitted in K990563 in that it The SC 6000 Authuned Communication of can process and display, from external devices:
MultiGas and MultiGas+ modules (K965062) Surgical Display Controller (K970348) Medical Information BUS Protocol Converter (MIB and MIB II) (K970368, K973222, K99166, K003248, and K010640)
A modification has been implemented in the SC 8000 Advanced Communication Option II to accommodate RJ45 connectors for interfacing to the MIB II Protocol Converter (K010640). The MIB II Protocol Converter supports the new IEEE 1073.3.2-2000, Standard for Medical Communications -Transport Profile - irDA Based - Cable Connected.
Intended Use:
The INFINITY SC 8000 monitor is intended for multi-parameter patient monitoring. The device will r no INT I 1 1 50 0000 months if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. This device will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.
| COMPANY CONFIDENTIAL | ||
|---|---|---|
| Siemens Medical Systems, Inc. | ||
| Electromedical Systems Group. PCS | 16 Electronics Avenue | |
| Danvers, MA 01923 | Tel: (978) 907-7500 | |
| Fax: (978) 750-6879 |
1
Assessment of non-clinical performance data for equivalence:_Section J
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances:
1073.3.2 - 2000 IEEE Standard for Medical Communications Transport Profile - IrDA Based - Cable Connected
2
COMPANY CONFIDENTIAL
Siemens Medical Systems, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers. MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the left and top of the emblem in a circular fashion. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2001
Ms. Penelone H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K012016
Trade Name: INFINITY SC 8000 with Advanced Communications Option II Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 MHX Dated: June 26, 2001 Received: June 28, 2001
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 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), You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 regulation 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
3
Page 2 - Ms. Penelope H. Greco
Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to ovegn mansoning your device of your device to a legally marketed notification. The PDA midning of substantal vour 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 If you desire specific as no room in devices), please contact the Office of Compliance at additionally 807.10 for m This allestions on the promotion and advertising of your device, (201) 594-4649. Truuntonally, 10. quice at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small . Information on your responsionnities and research or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Ken Miller
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_KO120 كا 20120)
Device Name: INFINITY SC 8000 Monitor_ Indications for Use:
The INFINITY SC 8000 Monitor is capable of monitoring:
- Heart rate ●
- Respiration rate .
- Invasive pressure ●
- Non-invasive pressure .
- Arrhythmia ◆
- . Temperature
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis .
- 12-Lead ST Segment Analysis .
- tcp02/tcpC02 .
- EEG signals .
- FiO2 ●
With the MultiGas and MultiGas+ modules the monitor is capable of measuring respiration rate, Inspired and expired Carbon Dioxide (CO2), inspired and expired Oxygen (MultiGas+ only), average inspired Oxygen (MultiGas only), inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.
With etCO2 the monitor can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode
With the INFINITY etCO2 + Respiratory Mechanics Pod the monitor can provide spirometric and carbon dioxide monitoring.
The monitor can interface with specific third party devices via an MIB protocol converter.
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 parameler Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediarric populations only; Arrhylhmia which is not intended for use in neonatal mode; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibility Statement:
The INFINITY SC 8000 Monitor is not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | --------------- | ---------------------- |
Division of Cardiovascular & Respiratory Devices (Optional Format 1-2-96)
| 510(k) Number | 12012016 |
|---|---|
| --------------- | ---------- |
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