(80 days)
No
The summary describes a critical care workstation that displays physiological parameters and DICOM images. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The device appears to be a display and interface system, not one that performs analysis using AI/ML.
No
The device is a display for physiological parameters and DICOM images; it does not directly provide therapy or affect the patient's medical condition.
No
Explanation: The device is described as a critical care workstation that displays physiological parameters and DICOM images. While it presents data relevant to patient care, it does not interpret or analyze that data to provide a diagnosis itself. The Healthcare Professionals are stated to be the ones who "determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition." This indicates the device is a tool for data display, not a diagnostic tool.
No
The device is described as a "critical care workstation" and mentions utilizing a software platform, but the description implies it is a hardware device that acts as a display and receives data, rather than being purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's primary function is to display physiological parameters received from patient monitors and display DICOM images. It acts as a display and workstation for data already acquired from the patient or from imaging systems.
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on specimens taken from the patient.
The device is a critical care workstation that integrates and displays data from other medical devices (patient monitors and imaging systems) for use by healthcare professionals in patient care. This falls under the category of medical devices used for monitoring and information display, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors (SC 7000/SC 9000XL / SC 8000) and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
Product codes (comma separated list FDA assigned to the subject device)
DXJ, MSX, LNX, LMD
MSX
Device Description
The INFINITY EXPLORER is a critical care workstation that acts as a display for physiological parameters received from an INFINITY patient monitor (SC 7000/SC 8000/SC 900712). Parameter Froom RER provides the user with a visual indication of alarms displayed (audio alarming and flashing visual indications are provided on the INFINITY patient monitor screen).
INFINITY EXPLORER utilizes the syngo (510k K010938) software platform and user interface common to other Siemens Medical modalities. INFINITY EXPLORER with syngo meeraeo common to edisplaying DICOM images retrieved from a syngo compatible SOITWate Is capacite of alleges Task Card provides access to DICOM images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM images
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal populations.
Intended User / Care Setting
healthcare environment where patient care is provided by healthcare professionals.
Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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)
Verification and validations tests have been performed which indicate that the INFINITY EXPLORER is as safe and effective as the predicate devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K980882, K983632, K003243, K010938
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
0
JAN 1 0 2002
510(k) SUMMARY
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: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco October 18, 2001 Date submission was prepared:
Trade Name, Common Name and Classification Name:
- A. Trade Name: Siemens INFINITY EXPLORER
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification
Number | Class | Regulation Number |
|--------------------------------------------------------------|--------------------------|-------|-------------------|
| Display, Cathode-ray tube, Medical | DXJ | II | 21 CFR 870.2450 |
| System, Network and Communication, Physiological
Monitors | MSX | | |
| Computers and Software, Medical | LNX | | |
| System, Digital Image Communications,
Radiological | LMD | 1 | 21 CFR 892.2020 |
Predicate Device Identification:
| K970348 | SC 9000 / SC 9015 Series Surgical Display Controller |
|---|---|
| K955059 | SC3000 MULTIVIEW WorkStation and Remote Display |
Other relevant submissions
| K980882 | SC 7000 / SC 9000XL |
|---|---|
| K983632 | SC 8000 |
| K003243 | INFINITY Modular Monitors Modifications |
| K010938 | syngo Multimodality Workstation |
1/4
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
Device Description:
Device Doseriping.
The INFINITY EXPLORER is a critical care workstation that acts as a display for physiological parameters received from an INFINITY patient monitor (SC 7000/SC 8000/ physionered. Parameter Froom RER provides the user with a visual indication of alarms SC 900712). Intrass displayed (audio alarming and flashing visual indications are provided on the INFINITY patient monitor screen).
INFINITY EXPLORER utilizes the syngo (510k K010938) software platform and user interface common to other Siemens Medical modalities. INFINITY EXPLORER with syngo meeraeo common to edisplaying DICOM images retrieved from a syngo compatible SOITWate Is capacite of alleges Task Card provides access to DICOM images.
Intended Use:
The INFINITY EXPLORER is a critical care workstation intended to display physiological The INTTT EAT BORDIC To a comy Modular Monitors and to visually display alarm data parameters rocerers. The device is capable of displaying DICOM images received over a hospital information system.
Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)
Assessment of clinical performance data for equivalence: Substantially equivalent (Section U)
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidance: Section R
2/4
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
ble of Device Similarities and differences to legally marketed dev
| Manufacturer | Legally Marketed Device
Olympus Communications Network, SC 3000
Workstation and Remote Display (MultiView
WorkStation and INFINITY Network)
Siemens Medical Systems | Legally Marketed Device
SC 9000/9015 Bedside Monitoring System
Surgical Display Controller | New Device
INFINITY EXPLORER | Explanation of Differences |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Intended Use | K955059
To act as a communications network, central monitoring device, and remote display for Siemens Patient Monitoring Systems and recorders | K970348
The Surgical Display Controller is to display SC 9000/9015 Bedside Monitor functions on a Siemens 15" Remote Display or on a standard video display | Same
To be determined
The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors (SC 7000/SC 9000XL / SC 8000) and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system. | The SC 7000 / SC 9000XL (K980882) and SC 8000 with Advanced Communication Option, 510(k) K990563 included the Surgical Display Controller |
| Intended
Environment | In a healthcare environment where patient care is provided by healthcare professionals. | Wherever the Siemens SC 9000 / 9015 Bedside Monitor is used | Wherever a Siemens INFINITY Monitor (SC 7000 / SC 8000/ SC 9000XL) is used | |
| Manufacturer | Legally Marketed Device
Olympus Communications
Network, SC 3000
Workstation and Remote
Display (MultiView
WorkStation and
INFINITY Network)
Siemens Medical Systems | Legally Marketed Device
SC 9000 / 9015 Bedside Monitoring
System
Surgical Display Controller | New Device
INFINITY EXPLORER | Explanation of Differences |
| 510(k) | K955059 | K970348 | Same | |
| Intended Population | Not connected to patients | Same | To be determined
Same | Although not connected
directly to patients, the
INFINITY EXPLORER is
intended to be used with the
same patient populations as
the INFINITY Modular
Monitors, Adult, Pediatric,
and Neonatal. |
| Display | Displays data received from the
patient monitor and the
INFINITY Telemetry System
via the INFINITY Network | User selectable. Independent from
bedside monitor's primary display | Same as K970348 | |
| Audible Alarm | Yes | No | No | |
| Visual Alarm | Yes | No | Yes | |
| Testing | | | | Verification and validations tests have been performed which indicate that the INFINITY EXPLORER is as safe and effective as the predicate devices |
OMPANY CONFIDENTIA
3/4
16 Electronics Avenue
Danvers, MA 01923
Siemens Medical Systems,
Electromedical Systems Group, PCS
.
Tel: (978) 907-7500
Fax: (978) 750-6879
3
510(k) Notification
INFINITY EXPLORE
16 Electronics Avenue
Danvers, MA 01923
OMPANY CONFIDENTIA
4/4
Siemens Medical Systems, Inc
Electromedical Systems Group, PCS
Tel: (978) 907-7500
Fax: (978) 750-6879
4
Image /page/4/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2002
Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K013515
Trade Name: Infinity Explorer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: MSX Dated: October 18, 2001 Received: October 22, 2001
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.
5
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,
N. Donnell
am D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Siemens INFINITY EXPLORER
Indications for Use:
This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use with the adult, pediatric and neonatal populations.
MRI Compatibility Statement:
The Siemens INFINITY EXPLORER 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)
LG Th
Division of Cardiovascular & Respiratory Devices
510(k) Number K013515