(53 days)
None
No Reference Device(s) K/DEN number are present in the text.
No
The summary describes a data transportation and aggregation software, with no mention of AI, ML, or related concepts.
No
The intended use explicitly states that "Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition." This indicates it's not a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition."
Yes
The intended use explicitly states "Cerner iBus is a software application" and describes its function as data transportation, aggregation, and derivation between medical devices and external systems. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Cerner iBus is for the "transportation, aggregation and derivation of data between medical devices and external systems." It explicitly states it is not intended to "directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition."
- IVD Definition: IVDs are medical devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. Cerner iBus does not perform this function. It handles data from medical devices, but it doesn't analyze biological specimens itself.
- Lack of IVD-Specific Information: The provided information lacks any details typically associated with IVDs, such as:
- Analysis of biological specimens.
- Specific analytes or markers being measured.
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.).
Therefore, Cerner iBus falls under the category of a medical device, but not an In Vitro Diagnostic device. It appears to be a data management and integration software for clinical settings.
N/A
Intended Use / Indications for Use
Cerner iBus is a software application intended for use in the transportation, aggregation and derivation of data between medical devices and external systems used in a clinical setting for the purpose of automating data collection and clinical information management.
Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Cerner iBus come into direct contact with patients.
Product codes
74 DRG
Device Description
Not Found
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
Not Found
Intended User / Care Setting
clinical setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic, emphasizing the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Cerner Corporation c/o Ms. Shelley S. Looby Director, Regulatory Affairs/Quality Assurance Cerner Corporation 2800 Rockcreek Parkway Kansas City, MO 64117
NOV 2 7 2009
Re: K093134
Trade/Device Name: Cerner CareAware™ iBus Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: 74 DRG Dated: October 2, 2009 Received: October 5, 2009
Dear Ms. Looby:
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 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.
1
Page 2 - Ms. Shelley S. Looby
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W.M.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K093134
Device Name: Cerner iBus
Indications for Use:
Cerner iBus is a software application intended for use in the transportation, aggregation and derivation of data between medical devices and external systems used in a clinical setting for the purpose of automating data collection and clinical information management.
Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Cerner iBus come into direct contact with patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use n/a (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRA, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K093134 |
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