CERNER CAREAWARE IBUS

K093134 · Cerner Corp. · DRG · Nov 27, 2009 · Cardiovascular

Device Facts

• Record ID: K093134
• Device Name: CERNER CAREAWARE IBUS
• Applicant: Cerner Corp.
• Product Code: DRG · Cardiovascular
• Decision Date: Nov 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Cerner CareAware iBus is a software application facilitating data interoperability in clinical environments. It functions as a middleware platform, aggregating and transporting physiological and clinical data from various medical devices to external information systems. The device does not contact patients, nor does it perform diagnostic or therapeutic functions. It automates data collection workflows, reducing manual entry requirements for clinicians. By centralizing data flow, it supports clinical information management, allowing healthcare providers to access integrated device data within existing hospital information systems. The system operates as a data conduit, ensuring information from bedside devices is available for clinical decision-making and electronic health record documentation.

Clinical Evidence

Bench testing only. No clinical data provided as the device is a software-based data integration and transport system that does not interact directly with patients or provide diagnostic/therapeutic outputs.

Technological Characteristics

Software-only application; functions as a data aggregation and transport middleware. Operates via network connectivity to interface between medical devices and external clinical information systems. No patient-contacting materials. Does not utilize energy for patient treatment or sensing; acts as a communication bridge.

Indications for Use

Indicated for use in clinical settings to automate data collection and clinical information management by transporting, aggregating, and deriving data between medical devices and external systems. Not for direct patient monitoring, diagnosis, treatment, or disease prevention.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## 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.

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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 [phone] or [phone] 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

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## 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)

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Concurrence of CDRA, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K093134 |

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