(62 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on displaying data and images, not on analytical or predictive capabilities.
No
This device is for displaying physiological parameters and DICOM images; it does not directly treat or diagnose a medical condition.
No
Explanation: The device displays physiological parameters and DICOM images but does not analyze or interpret them to provide diagnostic conclusions. It is a display and integration tool for healthcare professionals.
No
The device description explicitly states "This Special submission includes minor modifications to the hardware and software," indicating it is not solely a software device.
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 displays physiological parameters received from monitors and DICOM images. It's a display and integration tool for existing patient data and images.
- No mention of sample analysis: There is no indication that this device analyzes biological samples or performs any diagnostic tests on them.
The device's function is focused on presenting and integrating patient data and images for healthcare professionals to review and use in their assessment of the patient. This falls outside the scope of 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 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 Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
Product codes
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 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. This Special submission includes minor modifications to the hardware and software.
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
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.
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)
Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III.
Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Infinity Explorer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K060254
P 1/2
4 2006 APR
510(k) SUMMARY
as required per 807.92(c)
Draeger Medical Systems, Inc. Submitter's Name and Address: 16 Electionics Avenue Danvers, MA 01923 Karen Iorio Contact Person: Director QA/RA Ph: (978) 564-8364 Fax: (978) 750-6879 January 25, 2006 Date submission was prepared: Device Name: System, Network and Communication, Common Name: Physiological Monitors Classification Name: MSX Regulation Number: 21 CFR 870.2300 Class: 2 Legally Marketed Device Identification: Infinity Explorer
Device Description:
The Infinity Explorer is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors 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. This Special submission includes minor modifications to the hardware and software.
Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III.
1
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.
Substantial Equivalence:
Assessment of non-clinical performance data for equivalence:
Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidance: IEC 60601-1-1
2
Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text that is difficult to read. Inside the circle is a stylized symbol resembling three curved lines that converge and then diverge at the bottom, creating a shape that could be interpreted as a bird in flight or a stylized representation of water. The logo appears to be a simple, monochrome design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2006 APR
Draeger Medical Systems, Inc. c/o Mr. Thomas M. McIntosh Regulatory Affairs Manager 16 Electronics Avenue Danvers, MA 01923
Re: K060254
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: MSX Dated: March 17, 2006 Received: March 20, 2006
Dear Mr. McIntosh:
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.
3
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), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours.
Bhimman for
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_
Device Name: Infinity Explorer
Indications for Use
This device is capable of displaying physiological parameters received from Infinity Modular monitors 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:
Infinity Explorer is not compatible for use in a MRI magnetic field.
Prescription Use_ ) (Per 21 CFR 801.109)
OR Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummen
510/k) Numbe