(149 days)
Not Found
No
The description focuses on sensor data collection, wireless communication, and rule-based alerting based on parameters set by healthcare providers. There is no mention of AI/ML algorithms for data analysis, pattern recognition, or predictive capabilities.
No
The device monitors patient orientation and activity, and alerts healthcare providers, but it does not directly treat or diagnose a disease or condition. Its purpose is to aid in patient management, not to provide therapy.
No
Explanation: The device monitors patient orientation and activity to aid in turn management plans for preventing pressure ulcers. It does not diagnose a medical condition or disease, but rather provides data for patient management.
No
The device description explicitly states that DynaSense is comprised of hardware components including Patient Sensors, Relay Antennas, and a USB RF Transceiver, in addition to the software.
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.
- DynaSense Function: DynaSense monitors the physical orientation and activity of a patient. It does not analyze any biological samples or perform any tests on bodily fluids or tissues.
- Intended Use: The intended use is to aid in pressure ulcer prevention by monitoring patient movement and position, not to diagnose or detect a medical condition through laboratory analysis.
- Device Description: The device components (Patient Sensors, Relay Antennas, USB RF Transceiver, software) are designed for physical monitoring and data transmission, not for analyzing biological samples.
Therefore, DynaSense falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DynaSense monitors orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. DynaSense provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities.
Product codes
KMI
Device Description
DynaSense is a patient monitoring system that has been designed for use in hospitals, nursing homes, or other patient care facilities to aid standard care procedures for patients who are susceptible to pressure ulcers. The system monitors and reports patient activity and orientation as well as alerts the user (i.e., healthcare provider) when activity levels deviate from parameters set by healthcare providers. DynaSense is comprised of Patient Sensors, Relay Antennas, a USB RF Transceiver, Mesh Network Server Software, and User Interface software.
Each Patient Sensor is associated with a single patient, such that the patient's orientation and activity can be monitored. Data collected by the Patient Sensor is automatically communicated wirelessly to a nearby Relay Antenna, which subsequently relays these data to be displayed on the User Interface and maintained in a database. The system's Relay Antennas that are plugged into electrical outlets on the walls of the facility and the USB RF Transceiver that is plugged into the computer, on which the Mesh Network Server Software is installed or accessed, form a wireless network that allows data to be transmitted for display. The Mesh Network Server Software manages this network of Relay Antennas and USB RF Transceiver and collects the data from the Patient Sensors to allow monitoring of multiple patients on a single screen within the User Interface.
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
medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities.
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
Performance testing was conducted on DynaSense to support a determination of substantial equivalence to the predicate devices. The testing included the design verification (e.g., software verification), Electrical Safety, and Electromagnetic Compatibility testing. The collective results of the testing demonstrate that the chosen materials, the manufacturing processes, and design of DynaSense meet the established specifications necessary for consistent performance during its intended use. In addition, the collective testing results demonstrated that DynaSense does not raise new questions of safety or effectiveness for monitoring patient activity when compared to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2400 Bed-patient monitor.
(a)
Identification. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
SECTION 5 510(k) SUMMARY
510(k) Notification K
i
·
GENERAL INFORMATION
Applicant:
Centauri Medical, Inc. 37100 Central Court Newark, CA 94560 U.S.A. Phone: 510-574-0060 FAX: 510-574-0088
AUG 1 5 2013
Contact Person:
Lori Adels, Ph.D. Regulatory Consultant for Centauri Medical, Inc. Executive Vice President, Regulatory Affairs Experien Group, LLC 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 1-408-400-0856 ext. 112 FAX: 1-408-400-0865
Date Prepared: August 14, 2013
DEVICE INFORMATION
Trade Name:
DynaSense System
Generic/Common Name: Bed-patient monitor
Classification: 21 CFR§880.2400, Bed-patient monitor, Class I
Product Code: KMI, Monitor, Bed Patient
PREDICATE DEVICE(S)
1
INDICATIONS FOR USE
DynaSense monitors orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. DynaSense provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities.
DEVICE DESCRIPTION
DynaSense is a patient monitoring system that has been designed for use in hospitals, nursing homes, or other patient care facilities to aid standard care procedures for patients who are susceptible to pressure ulcers. The system monitors and reports patient activity and orientation as well as alerts the user (i.e., healthcare provider) when activity levels deviate from parameters set by healthcare providers. DynaSense is comprised of Patient Sensors, Relay Antennas, a USB RF Transceiver, Mesh Network Server Software, and User Interface software.
Each Patient Sensor is associated with a single patient, such that the patient's orientation and activity can be monitored. Data collected by the Patient Sensor is automatically communicated wirelessly to a nearby Relay Antenna, which subsequently relays these data to be displayed on the User Interface and maintained in a database. The system's Relay Antennas that are plugged into electrical outlets on the walls of the facility and the USB RF Transceiver that is plugged into the computer, on which the Mesh Network Server Software is installed or accessed, form a wireless network that allows data to be transmitted for display. The Mesh Network Server Software manages this network of Relay Antennas and USB RF Transceiver and collects the data from the Patient Sensors to allow monitoring of multiple patients on a single screen within the User Interface.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for DynaSense. DynaSense has the same intended use and similar technological characteristics as those of the predicate devices, the VivaTRAK System (K101109) and the MobileCare Monitor (K090138). Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, DynaSense is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Performance testing was conducted on DynaSense to support a determination of substantial equivalence to the predicate devices. The testing included the design verification (e.g., software verification), Electrical Safety, and Electromagnetic Compatibility testing. The collective results of the testing demonstrate that the chosen materials, the manufacturing processes, and design of DynaSense meet the established specifications necessary for consistent performance during its intended use. In addition, the
2
collective testing results demonstrated that DynaSense does not raise new questions of safety or effectiveness for monitoring patient activity when compared to the predicate devices.
CONCLUSION
DynaSense is a patient activity monitoring system, which provides the user with the patient's orientation and preset monitoring alerts. DynaSense has the same intended use and similar technological characteristics as those of the predicate devices, the VivaTRAK System and the MobileCare Monitor. Furthermore, device safety and performance testing have demonstrated that the device performs as intended in its intended use environment. As such, DynaSense is substantially equivalent to the predicate devices.
SUMMARY
DynaSense is substantially equivalent to the predicate devices.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird-like figure. The logo is black and white.
August 15, 2013
Centauri Medical, Incorporated C/O Lori Adels, Ph.D. Executive Vice President, Regulatory Affairs Experien Group. Limited Liability Company 755 North Mathilda Avenue. Suite 100 Sunnyvale, CA 94085
Re: K130752
Trade/Device Name: DynaSense System Regulation Number: 21 CFR 880.2400 Regulation Name: Bed-Patient Monitor Regulatory Class: I Product Code: KMI Dated: July 3. 2013 Received: July 5. 2013
Dear Dr. Adels:
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 reruse merce prior to May 28, 1976. the enactment date of the Medical Device Amendments. or to econimers 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. Iisting of devices, good manufacturing practice. Iabeling, 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
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Page 2 - Dr. Adels
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K130752
Device Name: DynaSense System
Indications For Use:
DynaSense monitors orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. DynaSense provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Richard C. | |
|---|---|
| .A | Chapman |
| 2013.08.15 | |
| 10:21:10 -0 |
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(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices K130752 510(k) Number: