(23 days)
Not Found
No
The summary describes a software application for displaying physiological parameters and DICOM images, with no mention of AI or ML capabilities.
No
The device is described as capable of displaying physiological parameters and alarm data, and DICOM images, which are monitoring and informational functions, not therapeutic actions.
No
The device is described as a display and viewing tool for physiological parameters and DICOM images, extending the capabilities of existing monitors. It does not perform analysis or interpretation for diagnosis.
Yes
The device is described as a "software-driven application" that runs on a "commercially available patient vicinity computer." While it interacts with hardware (monitors and computers), the device itself is the software component that provides the viewing and integration capabilities. The submission focuses on a software modification to run on a different computer, reinforcing its software-centric nature.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- 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 also allows for control back to the bedside and integration of other applications.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples or performing any tests on samples taken from the patient. Its function is focused on displaying and integrating data already acquired by other devices (patient monitors and imaging systems).
Therefore, while it's a medical device used in patient care, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 an 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.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors (SC 7000, 8000 9000XL) and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. In the initial release of the Infinity EXPLORER, the software was run on Siemens' own dedicated Medside Data Station (MDS), a patient vicinity computer based on Low Power Intel Pentium-III embedded processor.
The subject of this submission is a modification implemented that enables the INFINITY EXPLORER to run on a commercially available patient vicinity computer. With the release of software version VF2.1 the INFINITY EXPLORER has been tested for use with the Medside Data Station II (MDS II).
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.
Intended User / Care Setting
Healthcare Professionals, i.e. physicians, nurses, and technicians / critical care workstation in an environment where patient care is provided
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: Section J
Assessment of clinical performance data for equivalence: Not applicable
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.
Not Found
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
K030615
page 1 of 2
510(k) SUMMARY
as required per 807.92(c)
MAR 2 1 2003
Submitters Name, Address:
Siemens Medical Solutions, 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: February 24, 2003
Trade Name, Common Name and Classification Name:
A. Trade Name:
Siemens INFINITY Explorer
Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| System, Network and Communication, | |||
| Physiological Monitors | MSX | II | 870.2300 |
Legally Marketed Device Identification:
Siemens Infinity Explorer, 510(k) K013515
Description of Modification:
The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors (SC 7000, 8000 9000XL) and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. In the initial release of the Infinity EXPLORER, the software was run on Siemens' own dedicated Medside Data Station (MDS), a patient vicinity computer based on Low Power Intel Pentium-III embedded processor.
The subject of this submission is a modification implemented that enables the INFINITY EXPLORER to run on a commercially available patient vicinity computer. With the release of software version VF2.1 the INFINITY EXPLORER has been tested for use with the Medside Data Station II (MDS II).
Intended Use:
The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
1
COMPANY CONFIDENTIAL
Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
K030615
page 2 of 2
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: Section J
2
COMPANY CONFIDENTIAL
Siemens Medical Solutions, 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 21 2003
Siemens Medical Solutions, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923
Re: K030615
Trade Name: Infinity Explorer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: 74 MSX Dated: February 24, 2003 Received: February 26, 2003
Dear Ms. Greco:
We have reviewed your Section 510(k) premarket notification of intent to market the device feferenced 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.
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
3
Page 2 - Ms. Penelope H. Greco
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
J. Dela Tull
uckerman, M.D. ram D. Director Division of Cardiovascular Devices Office of Device Evaluation ' Center for Devices and Radiological Health
Enclosure
4
Page_1_of_1
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 an 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)
X Delatta
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K10308 15