(122 days)
The Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System 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.
The Leaf Patient Monitoring System is a medical device designed for use in hospitals, nursing homes, or other patient care facilities to monitor and report body orientation and activity, as well as to provide visual alerts for orientations and activity levels that fall outside of thresholds set by healthcare providers. The use of the Leaf Patient Monitoring System provides for continuous monitoring of patient position and allows caregivers to easily identify patients that are in need of caregiver-assisted turns according to the institution's guidelines or protocols. The use of the Leaf Patient Monitoring System can increase compliance with the care facility's prescribed patient tuning schedule and thereby may aid in the prevention of pressure ulcers.
The Leaf Patient Monitoring System is comprised of Patient Sensors, Leaf Antennas, and USB RF Transceivers, Turn Management Software, and a User Interface that can be viewed on a monitoring station. Each Leaf Patient Sensor is associated with a single patient, such that the patient's orientation, movements, and other care parameters can be monitored.
The provided text is a 510(k) premarket notification for the Leaf Patient Monitoring System. It focuses on demonstrating substantial equivalence to a predicate device (Centauri Medical, Inc. DynaSense System) rather than providing detailed acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device with performance metrics like sensitivity, specificity, etc.
Based on the provided document, here's an attempt to answer the questions, highlighting where information is not present as per the request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) for the Leaf Patient Monitoring System's performance in terms of monitoring patient orientation and activity, nor does it present specific reported performance metrics against such criteria. The focus is on demonstrating that the device "meets the established specifications necessary for consistent performance during its intended use" and "performs as intended."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "System performance testing" as part of nonclinical bench testing but does not specify a sample size, test set, or data provenance (country of origin, retrospective/prospective). It does not describe a clinical study with patients to validate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided as the document does not describe a clinical performance study involving expert-adjudicated ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
5. 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
An MRMC comparative effectiveness study was not mentioned or described. This device appears to be a monitoring system for patient orientation and activity, not an AI-assisted diagnostic imaging device that would typically involve human "readers." The system is designed to provide alerts and help caregivers with turn management, aiming to increase compliance with care facility protocols for pressure ulcer prevention.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "System performance testing" as part of nonclinical bench testing, implying standalone testing. However, the details of what this entailed (e.g., specific metrics for the algorithm's performance in detecting orientation changes) are not detailed. The device itself is described as a system that continuously monitors and communicates data wirelessly to a monitoring station that displays information via a user interface and provides alerts. Its purpose is to aid human caregivers rather than replace their decision-making entirely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for its "System performance testing." Given it's a patient monitoring system for orientation and activity, ground truth would likely involve direct observation or independent measurement of patient position/movement, but this is not stated.
8. The sample size for the training set
The document does not mention a training set or its sample size. This suggests that while the device contains software, a deep learning or similar AI model requiring a large training set may not be the core technology being described for performance evaluation in this submission. The "Software verification" mentioned is more likely related to traditional software engineering validation.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not provided.
Summary of what the document focuses on:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Centauri Medical, Inc. DynaSense System) based on:
- Identical intended use and indications for use.
- Similar technological characteristics, with minor modifications (updated aesthetics, minor display changes, related software updates, and a non-adhesive frame around the sensor adhesive).
- Labeling changes, specifically the removal of a contraindication for pacemaker/ICD patients with the addition of an appropriate warning statement, which was analyzed not to raise new issues of safety or effectiveness.
- Nonclinical Testing Summary: This included "System performance testing," "Software verification," and "Electrical Safety and EMC." The collective results are stated to "demonstrate that the materials chosen, the manufacturing processes, and design... meet the established specifications necessary for consistent performance" and "do not raise new questions of safety or effectiveness."
Essentially, the submission leverages the predicate device's prior clearance to establish safety and effectiveness, affirming that the new device is functionally the same or improved without introducing new risks that would necessitate extensive new clinical performance studies with detailed acceptance criteria and ground truth validation for novel AI algorithms.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10,2014
Leaf Healthcare Incorporated C/O Mr. Ronald S. Warren Experien Group, Limited Liability Company Senior Director - Regulatory Affairs 755 N Mathilda Avenue, Suite 100 Sunnyvale, CA 94085
Re: K141877
Trade/Device Name: Leaf Patient Monitoring System Regulation Number: 21 CFR 880.2400 Regulation Name: Bed-Patient Monitor Regulatory Class: I Product Code: KMI Dated: October 13, 2014 Received: October 14, 2014
Dear Mr. Warren:
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. 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.
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Page 2 - Mr. Warren
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runner DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K141877
Device Name Leaf Patient Monitoring System
Indications for Use (Describe)
The Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System provides alerts when patient 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Notification K___________
GENERAL INFORMATION
Applicant:
Leaf Healthcare, Inc. 5994 West Las Positas Boulevard, Suite 217 Pleasanton, CA 94588 U.S.A. Phone: 925-621-1800 FAX: 925-621-1801
Contact Person:
Ronald S. Warren Regulatory Consultant for Leaf Healthcare, Inc. Experien Group, LLC 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 1-408-505-3926 FAX: 1-408-400-0865
Date Prepared: July 10, 2014
DEVICE INFORMATION
Trade/Proprietary Name: Leaf Patient Monitoring 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
- Centauri Medical, Inc. DynaSense System (K130752)
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INDICATIONS FOR USE
The Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System 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 DESCRIPTION
The Leaf Patient Monitoring System is a medical device designed for use in hospitals, nursing homes, or other patient care facilities to monitor and report body orientation and activity, as well as to provide visual alerts for orientations and activity levels that fall outside of thresholds set by healthcare providers. The use of the Leaf Patient Monitoring System provides for continuous monitoring of patient position and allows caregivers to easily identify patients that are in need of caregiver-assisted turns according to the institution's guidelines or protocols. The use of the Leaf Patient Monitoring System can increase compliance with the care facility's prescribed patient tuning schedule and thereby may aid in the prevention of pressure ulcers.
The Leaf Patient Monitoring System is comprised of Patient Sensors, Leaf Antennas, and USB RF Transceivers, Turn Management Software, and a User Interface that can be viewed on a monitoring station. Each Leaf Patient Sensor is associated with a single patient, such that the patient's orientation, movements, and other care parameters can be monitored.
TECHNOLOGICAL CHARACTERISTICS
The Leaf Patient Sensor is a small, disposable sensor that adheres to a patient's skin, much like a standard electrocardiogram (EKG) lead. Once the Leaf Patient Sensor is applied to a particular patient, it continuously monitors the patient's orientation and movements and communicates this data wirelessly (via the Leaf Antennas) to a monitoring station that is equipped with a USB RF Transceiver and the Leaf Turn Management Software. The Leaf Turn Management Software collects and records all data for the Patient Sensors. Data for all monitored patients is ultimately displayed on the Leaf User Interface. Through the Leaf User Interface, caregivers can associate Patient Sensors with specific patients and also set individualized care parameters.
Multiple Leaf Antennas are installed throughout a monitoring environment to ensure adequate wireless coverage for a given area, such as a hospital ward or nursing unit.
Compared to the predecessor Centauri DynaSense device, the Leaf Patient Monitoring System has been updated with several minor modifications. These include updated aesthetics of the user interface, minor changes to the display features for user convenience and related software updates. The adhesive used to apply the device to the patient is unchanged, but a non-adhesive frame has been added around the adhesive to facilitate device removal from the patient's skin.
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LABELING
One contraindication from the predicate IFU pertaining to the use of the system's sensor in patients who have a pacemaker or an implantable cardioverter-defibrillator (ICD), has been removed. Leaf Healthcare determined the system's sensor may be safely used in this subpopulation of patients, when an appropriate warning statement is provided to the user. A warning statement has been added to the IFU in order to safely enable the use of the device in this subpopulation of patients.
SUBSTANTIAL EQUIVALENCE
Aside from minor semantic differences such as the product name change, the indications for use for the Leaf Patient Monitoring System are identical to the indications for use for the predicate DynaSense System. The Leaf Patient Monitoring System and the predicate DynaSense System have the same intended use. The minor differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Leaf Healthcare analyzed the removal of the contraindication and addition of the warning statement to enable use of the device in patients with a pacemaker/ICD, and determined that these modifications raise no new issues of safety or effectiveness. Thus, the Leaf Patient Monitoring System is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the Leaf Patient Monitoring System to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- . System performance testing;
- Software verification; ●
- 0 Electrical Safety and EMC.
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Leaf Patient Monitoring System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective nonclinical testing results demonstrate that the Leaf Patient Monitoring System does not raise new questions of safety or effectiveness for monitoring patient activity when compared to the predicate device.
CONCLUSION
The Leaf Patient Monitoring System and the predicate DynaSense System have the same intended use and similar technological characteristics. The minor differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Device safety and performance testing have demonstrated that the Leaf Patient Monitoring System performs as intended in its intended use environment, and support the device performs at least as safely and effectively as the predicate DynaSense System.
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SUMMARY
The Leaf Patient Monitoring System is substantially equivalent to the predicate device.
§ 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.