(26 days)
No
The document describes standard patient monitoring technology and software updates, with no mention of AI or ML algorithms for data analysis, prediction, or interpretation.
No
The device is a multi-parameter patient monitor that measures and displays physiological parameters. It is intended for monitoring and detection, not for treating or preventing illness.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are intended for "multi-parameter patient monitoring" and list numerous physiological parameters that they are capable of monitoring. While they produce alarms, the primary function of monitoring these parameters is for diagnostic purposes, allowing healthcare professionals to assess a patient's condition.
No
The device is described as "INFINITY Modular Monitors" and includes descriptions of hardware components like a wireless ethernet adapter, PCMCIA port, serial port, and adapter cables for sensors. The software modifications are described as updates to the functionality of these hardware monitors.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The INFINITY Modular Monitors are described as "multi-parameter patient monitoring" devices. They measure physiological parameters directly from the patient (e.g., heart rate, blood pressure, oxygen saturation, gas concentrations in respiration).
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient. All measurements appear to be taken on the patient.
Therefore, the INFINITY Modular Monitors fall under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to a Siemens R50 Bedside recorder, either directly or via the INFINITY Network.
Product codes
MHX, 74DSI
Device Description
The modifications implemented with the release of software version VF2 have not altered the basic fundamental technology of the INFINITY Modular Monitors. Testing with VF2 software indicates no new issues relative to safety and efficacy. The release of software version VF2 includes the following primary modifications:
-
- Wireless capability
- Non-invasive blood pressure with step deflation 2.
-
- MICRO2+(K012770) interface
- Support for Masimo sensors 4.
The INFINITY Modular Monitors (SC 7000 / SC 9000XL) with Wireless Option (a password protected option) allows the monitor to operate in a wireless network configuration. A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.
The Infinity Monitoring System utilizes the oscillometric method to measure noninvasive blood pressure (NIBP). With the SC7000/8000/9000XL VF2 release, the NIBP algorithm has changed from a linear to stepped deflation system.
The INFINITY Modular Monitor (SC 7000 / SC 8000 / SC 9000XL) VF2 release supports two simultaneous SpO2 measurements. Using a serial port already available on the monitors, the MicrO2+ pulse oximeter (K012770) can communicate with the monitors using a RS232 serial communication and power supply cable connected to the serial port on the monitor. The stand-alone MicrO2+ pulse oximeter transmits SpO2 and Pulse values to the monitor.
The monitor supports the use of Masimo SpO2 sensors via a password protected option and a specific adapter cable.
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, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only: etCO2 sidestream which is not available 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 devices are 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Assessment of non-clinical performance data for equivalence: See Section J
Assessment of clinical performance data for equivalence: See Section J
Clinical accuracy studies referenced to cooximetry (see Section J) were conducted by Masimo using the following sensors in conjunction with the INFINITY Modular monitors:
- . LNOP-Adt
- . LNOP-Pdt
- LNOP-Neo ●
- LNOP-NeoPt ●
- LNOP-DCI .
- LNOP-DCIP .
- . LNOP-YI
- LNOP-Ear .
- NR 125 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983632, K990563, K003243, K982730, K980882
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
510(k) SUMMARY
as required per 807.92(c)
Submitters Name. Address:
SEP 2 5 2002
Siemens Medical Solutions USA, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: August 29, 2002
Trade Name, Common Name and Classification Name:
A. Trade Name:
Siemens INFINITY Modular Monitors (SC 7000 / SC 9000XL / SC 8000)
- B. 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:
INFINITY SC 8000 Monitor, 510(k) K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, 510(k) K003243/K982730/ K980882 INFINITY Explorer, 510(k) K013515 MICRO2+, 510(k) K012770
Description of Modification:
The modifications implemented with the release of software version VF2 have not altered the basic fundamental technology of the INFINITY Modular Monitors. Testing with VF2 software indicates no new issues relative to safety and efficacy. The release of software version VF2 includes the following primary modifications:
-
- Wireless capability
- Non-invasive blood pressure with step deflation 2.
-
- MICRO2+(K012770) interface
- Support for Masimo sensors 4.
1 of 3
Siemens Medical Solutions USA, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
The INFINITY Modular Monitors (SC 7000 / SC 9000XL) with Wireless Option (a password protected option) allows the monitor to operate in a wireless network configuration. A wireless ethernet adapter installed in the PCMCIA port communicates with the INFINITY Network (K955059) through installed access points hardwired to the network. All patient related and network data is transmitted to the pre-installed access points allowing the transmitted data from the monitor to be viewed at an assigned MultiView WorkStation (K955059). This configuration provides the network with the same functionality as a hardwired system.
NIBP Step Deflation
The Infinity Monitoring System utilizes the oscillometric method to measure noninvasive blood pressure (NIBP). With the SC7000/8000/9000XL VF2 release, the NIBP algorithm has changed from a linear to stepped deflation system.
Second SpO2 - MICRO2+ Interface
The INFINITY Modular Monitor (SC 7000 / SC 8000 / SC 9000XL) VF2 release supports two simultaneous SpO2 measurements. Using a serial port already available on the monitors, the MicrO2+ pulse oximeter (K012770) can communicate with the monitors using a RS232 serial communication and power supply cable connected to the serial port on the monitor. The stand-alone MicrO2+ pulse oximeter transmits SpO2 and Pulse values to the monitor.
Support for Masimo Sensors
The monitor supports the use of Masimo SpO2 sensors via a password protected option and a specific adapter cable. Clinical accuracy studies referenced to cooximetry (see Section J) were conducted by Masimo using the following sensors in conjunction with the INFINITY Modular monitors:
- . LNOP-Adt
- . LNOP-Pdt
- LNOP-Neo ●
- LNOP-NeoPt ●
- LNOP-DCI .
- LNOP-DCIP .
- . LNOP-YI
- LNOP-Ear .
- NR 125 ●
2 of 3
Siemens Medical Solutions USA, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Intended Use:
The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices 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 J
Assessment of clinical performance data for equivalence: See Section J
Biocompatability: Not applicable
Sterilization: Not applicable
See Section J Standards and Guidances:
3 of 3
Siemens Medical Solutions USA, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with three bars above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 25 2002
Siemens Medical Solutions USA, Inc c/o Ms. Penelope H. Greco Regulatory Submissions Manager Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K022889
Trade Name: Siemens Medical INFINITY Modular Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: August 29, 2002 Received: August 30, 2002
Dear Ms. Greco:
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.
4
Page 2 - Ms. Penelope H. Greco
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 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.
Elias Mallis
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO22889 510(k) Number (if known):
.Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The INFINITY Modular monitors are capable of monitoring:
- Heart rate
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Arrhythmia
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- Apnca
- ST Segment Analysis
- 12-Lead ST Segment Analysis
- tcp02/tcpC02
- EEG signals
- FiO2
With the MultiGas and MultiGas+ modules the monitors are 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 monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are 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 devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Qutput, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only: etCO2 sidestream which is not available 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 Modular Monitors are 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 | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | Elico Malles |
|---|---|
| --------------- | -------------- |