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.

AI/ML Overview

The Centauri Medical, Inc. DynaSense System, a bed-patient monitor, was reviewed for substantial equivalence (K130752). The device is intended to monitor patient orientation and activity to aid in pressure ulcer prevention.

Acceptance Criteria and Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or a detailed table of device performance against such criteria. Instead, it broadly states that "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." It also concludes that the device "does not raise new questions of safety or effectiveness for monitoring patient activity when compared to the predicate devices."

The study described primarily focuses on qualitative assessments and established engineering standards to demonstrate substantial equivalence to predicate devices (Wireless MedCARE VivaTRAK™ System (K101109) and AFrame Digital MobileCare Monitor™ (K090138)).

Key Information from the Study:

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Type	Reported Device Performance
Design Verification (e.g., software verification)	The collective results of testing demonstrate that the design meets established specifications necessary for consistent performance.
Electrical Safety Testing	The collective results of testing demonstrate that the device performs as intended in its intended use environment and does not raise new questions of safety or effectiveness.
Electromagnetic Compatibility (EMC) Testing	The collective results of testing demonstrate that the device performs as intended in its intended use environment and does not raise new questions of safety or effectiveness.
Safety and Effectiveness compared to Predicate Devices	"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." Implies performance comparable to predicate devices in terms of patient activity monitoring, orientation tracking, and alert functionality to aid in pressure ulcer prevention. The device has "the same intended use and similar technological characteristics" as the predicate devices, with no differences raising new safety or effectiveness concerns. The device “performs as intended in its intended use environment.”

Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size of a test set, nor does it detail the specific data provenance (e.g., country of origin, retrospective/prospective). The performance testing mentioned is "design verification (e.g., software verification), Electrical Safety, and Electromagnetic Compatibility testing," which are typically conducted in a laboratory or controlled environment rather than with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The testing described focuses on engineering validation and regulatory compliance, not clinical performance assessed by experts against a ground truth in a clinical setting.
Adjudication method for the test set:

This information is not provided. Given the nature of the testing (design, electrical, EMC), clinical adjudication methods would not typically apply.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done, as this is a patient monitoring device, not an imaging interpretation or diagnostic AI tool that would involve human "readers" or AI assistance for interpretation. The device itself provides alerts to healthcare providers based on set parameters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a standalone monitoring system. It operates to detect patient orientation and activity and generate alerts based on predefined parameters. The "human-in-the-loop" component is where healthcare providers respond to these alerts and use the information to implement turn management plans. The core functionality of monitoring and alerting is performed by the algorithm/system autonomously.
The type of ground truth used:

The document does not specify a "ground truth" in the clinical sense (e.g., pathology, outcomes data). The "ground truth" for the engineering tests would be the established specifications and accepted standards for electrical safety, EMC, and software functionality. For example, in electrical safety testing, the ground truth is adherence to voltage, current, and insulation limits.
The sample size for the training set:

This information is not provided. The development of monitoring systems like DynaSense typically involves engineering design, calibration, and validation, rather than the "training set" concept common in machine learning or AI models developed from large datasets. While there is "Mesh Network Server Software" and "User Interface software," the description does not suggest a deep learning or similar AI model that would require a distinct "training set" for classification or prediction tasks.
How the ground truth for the training set was established:

This information is not applicable, as no explicit "training set" in the context of machine learning/AI models is mentioned. Rather, the device's functionality is based on programmed logic and sensor data interpretation.

Summary

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SECTION 5 510(k) SUMMARY

510(k) Notification K

K130752

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)

Wireless MedCARE VivaTRAK™ System (K101109) ●
AFrame Digita! MobileCare Monitor™ (K090138) .

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INDICATIONS FOR USE

DEVICE DESCRIPTION

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

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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

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SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130752

Device Name: DynaSense System

Indications For Use:

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

4'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices K130752 510(k) Number:

Regulation Number and Section

§ 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.