(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.
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SEP 2 6 2011
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GE Healthcare
Centricity® Perinatal and Centricity Intensive Care - 510(k) Premarket Notification
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 2011-Mar-04 |
|---|---|
| Submitter: | GE Healthcare - HCIT540 W Northwest HighwayBarrington, IL, USA, 60010-3076 |
| Primary Contact Person: | Nicole LandrevilleUSA Premarket Regulatory Affairs LeaderGE Healthcare, QARA Regions - Americas3000 North Grandview Boulevard #W450Waukesha, WI, USA, 53188T: (289) 208-2365F: (414) 918-4498 |
| Secondary Contact Person: | Jeme WallaceDirector Regulatory AffairsGE Heathcare IT540 W Northwest HighwayBarrington, IL, USA, 60010-3076T (847) 277-4468F (847) 939-1446 |
| Device/Trade Name: | Centricity® Perinatal and Centricity Intensive Care |
| Common/Usual Name: | Centricity® Perinatal and Centricity Intensive Care, CPN, CentricityPerinatal |
| Classification Names: | Perinatal monitoring system and accessories. |
| Product Code: | HGM 884.2740 |
| Predicate Device(s): | Centricity® Perinatal and Centricity Intensive Care [Formallyknown as Quantitative Sentinel (QS) System] |
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Image /page/1/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.
GE Healthcare
Centricity® Perinatal and Centricity Intensive Care - 510(k) Premorket Notification
| Device Description: | The Centricity® Perinatal and Centricity Intensive Care is a datamanagement tool. |
|---|---|
| The basis for this submission is a modification to a legallymarketed device. Both the proposed device intended use andindications for use statements are equivalent to that of thepredicate device and have been reworded to improve clarity. | |
| Since 1999, Data Management Computer Systems andTechnology have evolved. GEHC has modified the device byincorporating "state of the art" technology. The most significantchanges being listed are: Overall product enhancements forsecurity and privacy (to support HIPAA), interoperabilityenhancements, clinician notification enhancements, removal ofsome features only supplied on the old OS/2 platform version,keeping up with technology changes with respect to WindowsOperating system, etc. On their own, none of these changeswould have triggered a 510k submission. However, it wasdeemed important to clarify the Intended Use and Indications foruse as well as to notify FDA of the current product state sincemany changes were made to keep up with the evolution oftechnology. |
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Image /page/2/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.
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GE Healthcare
Centricity® Perinatal and Centricity Intensive Care - 510(k) Premarket Notification
| Intended Use: | 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. |
|---|---|
| Indications for Use: | 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)PostpartumNewborn NurseryCritical 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 devicesExternal 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. | |
| Technology: | The Centricity® Perinatal and Centricity Intensive Care employs the same fundamental scientific technology as its predicate devices. |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Jeme Wallace Director Regulatory Affairs GE Healtheare 540 W Northwest Highway BARRINGTON II. 60010
EP 2 6 2011
Re: K111614
Trade/Device Name: Centricity® Perinatal and Centricity Intensive Care Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: H Product Code: HGM. MSX Dated: August 19, 2011 Received: August 23, 2011
Dear Ms. Wallace:
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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 of medical device-related
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Page 2
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/CDRH0ffices/ucm115809.html 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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510(k) Number (if known): K111614
| Device Name: | |
|---|---|
Centricity® Perinatal and Centricity Intensive Care
Intended Use:
Centricity® Perinatal and Centricity Intensive Care is intended to be used in clinical departments of healthcare delivery systems such as Labor and Delivery, Postpatum Maternal Care, Newborn Nursery, critical care units including Neonatal Intensive Care Units (NCU), and may also be used in physician offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to serve the purpose
store and manage cinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System card is accept, fransfer, display, calcula
data from medical data. System cata and the user with the ability to acquire data from medical devices and to document, annotate, display, store, print, export and retrieve patient/clinical practice and to doomini, annotate, useplay, store, professional use only,
Indications for Use:
The Centricity Perinatal and Centricity Intensive Care (CPN-CIC) is a clinical information system used to manage clinical de Sentions intersive Care (CPN-ClC) is a clinical information system
as: 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 decident at regular and/or intentions. Features of the product and will have bland on treatments
should be used in combination with other alinied to support clinical decision making and should be used in continution with other clinical interior of the projection making a physical exam findings and information contained within other systems or recording tods. The product is not intended to be used as a primary monitoring or diagnostic device.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE - Continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, andUrological Devices | |
| 510(k) Number | K111614 |
§ 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).