(110 days)
Centricity® Perinatal and Centricity Intensive Care is intended to be used as a data management tool with which a medical institution may define electronic forms to acquire device data and to document, annotate, display, store, print, export and retrieve patient/clinical practice information. This product is a primary tool for documentation as well as an adjunct tool for surveillance.
The Centricity Perinatal and Centricity Intensive Care (CPN-CIC) is a clinical information system used to manage clinical data. The CPN-CIC may be used in the following clinical settings such as:
- Labor and Delivery (Antepartum, Intrapartum)
- Postpartum
- Newborn Nursery
- Critical Care Units (Neonatal Intensive Care, Adult Intensive Care)
The CPN-CIC can be used in the hospitals, physician offices, and outpatient clinics where the system can accept and display data from the following sources such as:
- Physiologic devices
- External hospital and clinical information systems
NOTE: This product does not replace clinical observation and evaluation of the patient at regular intervals by a qualified healthcare provider, who will make diagnoses and decide on treatments and/or interventions. Features of the product are intended to support clinical decision making and should be used in combination with other clinical inputs, such as real time patient observation, physical exam findings and information contained within other systems or recording tools. The product is not intended to be used as a primary monitoring or diagnostic device.
The Centricity® Perinatal and Centricity Intensive Care is a data management tool.
The basis for this submission is a modification to a legally marketed device. Both the proposed device intended use and indications for use statements are equivalent to that of the predicate device and have been reworded to improve clarity.
Since 1999, Data Management Computer Systems and Technology have evolved. GEHC has modified the device by incorporating "state of the art" technology. The most significant changes being listed are: Overall product enhancements for security and privacy (to support HIPAA), interoperability enhancements, clinician notification enhancements, removal of some features only supplied on the old OS/2 platform version, keeping up with technology changes with respect to Windows Operating system, etc. On their own, none of these changes would have triggered a 510k submission. However, it was deemed important to clarify the Intended Use and Indications for use as well as to notify FDA of the current product state since many changes were made to keep up with the evolution of technology.
The provided document is a 510(k) summary for the GE Healthcare Centricity® Perinatal and Centricity Intensive Care system. It describes the device, its intended use, and indications for use, and confirms substantial equivalence to a predicate device.
However, the document does not contain information related to specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.
The submission states that the basis for this 510(k) is a modification to a legally marketed device. The changes primarily relate to "Overall product enhancements for security and privacy (to support HIPAA), interoperability enhancements, clinician notification enhancements, removal of some features only supplied on the old OS/2 platform version, keeping up with technology changes with respect to Windows Operating system, etc."
It explicitly states: "On their own, none of these changes would have triggered a 510k submission. However, it was deemed important to clarify the Intended Use and Indications for use as well as to notify FDA of the current product state since many changes were made to keep up with the evolution of technology."
Therefore, this 510(k) is focused on demonstrating substantial equivalence for an updated version of an existing device, primarily due to technological updates and clarity in intended use/indications, rather than presenting a de novo performance study against defined acceptance criteria for a novel functionality.
Based on the provided document, I cannot fulfill the request as it asks for information not present in the given text.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).