Who is the manufacturer of PRESSUREALERT® Pressure Monitoring System?

Position Health, LLC filed the 510(k) submission for PRESSUREALERT® Pressure Monitoring System (K233096).

What is the FDA product code for PRESSUREALERT® Pressure Monitoring System?

SBO. It is classified under 21 CFR 880.2400 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for PRESSUREALERT® Pressure Monitoring System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PRESSUREALERT® Pressure Monitoring System?

Leaf Patient Monitoring System (K141877).

Who can help prepare an FDA 510(k) submission like PRESSUREALERT® Pressure Monitoring System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PRESSUREALERT® Pressure Monitoring System

K233096 · Position Health, LLC · SBO · Jun 21, 2024 · General Hospital

Device Facts

Record ID	K233096
Device Name	PRESSUREALERT® Pressure Monitoring System
Applicant	Position Health, LLC
Product Code	SBO · General Hospital
Decision Date	Jun 21, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2400
Device Class	Class 1

Indications for Use

The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to execute an individualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the 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 Story

System monitors soft tissue pressure at up to 11 body sites (e.g., sacrum, heels, hips) to prevent pressure ulcers. Consists of wireless pressure-sensing dressing assemblies and management software. Sensors measure pressure; when levels exceed provider-set thresholds, system alerts healthcare staff via Android tablet or web portal. Used in professional facilities (nursing, rehab) to support individualized turn management protocols. Provides real-time monitoring and reporting of pressure events and repositioning status. Benefits patients by reducing risk of soft tissue damage from prolonged pressure on bony prominences.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ingress protection (IP4X, IPX7), drop testing, battery life (25 days activated), and pressure sensor performance (activation threshold 32 mmHg).

Technological Characteristics

Wireless pressure-sensing dressing assembly; silicone skin adhesive (ISO 10993 compliant); 2.4 GHz wireless transmission; 3 VDC internally powered sensors. System includes Android tablet interface and cloud-based server. Software follows IEC 62304. Sterilization: Non-sterile.

Indications for Use

Indicated for patients susceptible to pressure ulcers in medical, nursing, and long-term care facilities. Not for use in patients under 18, pregnant women, or the morbidly obese (BMI 40+).

Regulatory Classification

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.

Predicate Devices

Leaf Patient Monitoring System (K141877)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 21, 2024 Walgreen Health Solutions, LLC % Yolanda Smith Consultant Smith Assoicates 1468 Harwell Ave Crofton, Maryland 21114 Re: K233096 Trade/Device Name: PRESSUREALERT® Pressure Monitoring System Regulation Number: 21 CFR 880.2400 Regulation Name: Bed-Patient Monitor Regulatory Class: Class I Product Code: SBO Dated: May 20, 2024 Received: May 21, 2024 Dear Yolanda Smith: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. David Walloschek David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors {2}------------------------------------------------ OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233096 Device Name PRESSUREALERT® Pressure Monitoring System #### Indications for Use (Describe) The PRESSUREALERT® Pressure Monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to medividualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the healthcare providers. The device is in medical, nursing, and longterm care facilities including independent living, assisted living, and rehabilitation facilities. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary K233096 | Name: | Walgreen Health Solutions, LLC | |--------------------|-------------------------------------------------| | Address: | 1316 Sherman Avenue Evanston, Illinois 60201 | | Telephone: Fax: | 847-328-9540 847-328-7950 | | Contact Person: | Dawn Bolles Regulatory Specialist | | Telephone: | 847-563-0270 | | eMail: | dawnbolles@walgreenhealthsolutions.com | #### 2. Date Summary was prepared: June 18, 2024 # 3. Device Information: | Trade Name: | PRESSUREALERT® Pressure Monitoring System | |----------------------|-------------------------------------------| | Common Name: | Bed-patient activity monitoring system | | Classification Name: | Bed-patient monitor | | Review Panel: | General Hospital | | Class: | Class I | | Product Code: | SBO | | CFR Regulation: | 21 CFR 880.2400 | # 4. Predicate Device | | Manufacturer | Trade Name | 510(k) Number | Product Code | |----------------------|---------------------------------|--------------------------------------|---------------|--------------| | Primary Predicate | Leaf Healthcare Incorporated | Leaf Patient Monitoring System | K141877 | KMI | ### 5. Product Description The PRESSUREALERT® Pressure Monitoring System is composed of a wireless pressure sensing dressing assembly as part of a system supported by the PRESSUREALERT® Management Software for providing a warning to the healthcare provider that soft tissue pressure has exceeded a predetermined level that, over a period of {5}------------------------------------------------ time, would necessitate that the patient should be moved to prevent or at least reduce the risk of soft tissue damage. The PRESSUREALERT® Pressure Monitoring System functions as a pressure monitoring system with the primary function to monitor a patient that is laying down on their back or otherwise in a position that may result in the patient's weight applying pressure to an area of the patient's body that is susceptible to pressure ulcers/injuries, such as soft tissue overlying a bony prominence. The dressing assembly, with the enclosed pressure sensor, is applied on the patient's body that is susceptible to damage from soft tissue pressure. The identified areas are referred to as "at-risk" in the instructional documentation and intended use and include up to eleven (11) sites defined as the upper spine, head-skull, hip (right or left), Ischia (right or left), heels and elbows (right or left), and sacrum. (See Product Comparison Table in Section 7) The material components of the PRESSUREALERT® Pressure Monitoring System, and described in detail in the Device Description section, includes: - i. PRESSUREALERT® Segmented Oval Dressing - ii. PRESSUREALERT® Round Dressing - iii. PRESSUREALERT® Sacral Dressing - iv. PRESSUREALERT® Oval Sensor - v. PRESSUREALERT® Round Sensor # 6. Indications for Use The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to execute an individualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the healthcare providers. The device is intended for use in medical, nursing, and long-term care facilities including independent living, assisted living, and rehabilitation facilities. {6}------------------------------------------------ # 7. Predicate Product Comparison Table | Attributes | Subject Device | Predicate Device | Comments | |-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K233096 | K141877 | | | Device Name | PRESSUREALERT® Pressure Monitoring System | Leaf® Patient Monitoring System | | | Manufacturer | Walgreen Health Solutions, LLC | Leaf Healthcare, Inc. | | | Class | Class I | Class I | Same | | Classification Regulation | 21 CFR §880.2400 | 21 CFR §880.2400 | Same | | Regulation Name | Bed-Patient Monitor | Bed-Patient Monitor | Same | | Indications for Use | The PRESSUREALERT® Pressure Monitoring System monitors the activity of patients who are susceptible to pressure ulcers by measuring pressure at various points of the body. It allows healthcare providers to execute an individualized turn management plan for each patient by continuously monitoring pressure on various points of the body of each patient. The PRESSUREALERT® Pressure Monitoring System provides alerts when patient activity deviates from the pressure prevention parameters set for by the 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 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. | Similar for use in the prevention of pressure ulcer formation and execution of individualized turn management patient plans. The subject device can be placed on multiple parts of the body as compared to the predicate device which is placed in only 1 location as described in (Section 8) The Discussion of Technological Differences, Body Site Location and the differences raises no new issues of safety and effectiveness. | | Principle of Operation | Wearable pressure sensor (inserted into a dressing and attached to patients' skin) functions to provide monitoring of selected "at risk" body locations and alarm if meets pressure level thresholds related to pressure ulcer formation. Table pressure | Wearable sensor attached to patients' skin and a display monitor for turn status and alerts. Wearable sensor that provides reminders and tracking of patient repositioning and turning in order to prevent | Similar, supports patient repositioning protocol. The Discussion of Technological Differences (Section 8), Body Site Location, refers to the differences in the | | Attributes | Subject Device | Predicate Device | Comments | | | different pressure and alarm when threshold met. Bedside tablet and remote monitoring provide reporting on pressure events and repositioning reporting to support effective patient repositioning protocol. | | subject device operations and raises no new issues of safety and effectiveness. | | Intended Population | The PRESSUREALERT® Pressure Monitoring System is not intended for use with patients under the age of 18, pregnant women, or the morbidly obese (Class 3, BMI 40 or greater). Safe use for patients under the age of 18, pregnant women, and the morbidly obese has not been established. | The Leaf Patient Monitoring System has not been tested on women who are pregnant or breastfeeding, so the risks to unborn fetuses and nursing children are unknown. Safety and effectiveness for use by pregnant women and children (under the age of 18) has not been established. | Similar, the predicate device indication does not include the morbidly obese potentially due to the placement location on the patient (single site, chest). The subject device can be utilized on up to 11 body site locations and the morbidly obese require special repositioning protocol, staff, and equipment that could interfere with the sensor. This contraindication raises no new issues of safety and effectiveness. | | Intended Use Environment | The device is for use in professional healthcare facilities only including independent living, assisted living, and rehabilitation facilities. | The device is intended for use in medical, nursing, and long-term care facilities, including independent living, assisted living, and rehabilitation facilities. | Same | | Prescription | Yes | Yes | Same | | Single Use | Sensor Dressing Only (Sensor No) | No | Same | | Sterile | No | No | Same | | Single Patient – Multiple Use | Sensor Only | Yes (on label of Sensor) | Same | | Sensor Size | Round Sensor - placed in round or sacral dressing foam pocket: Oval Sensor - placed into oval segmented dressing foam pocket: | Sensor Single 1.8" x 2.0", | The subject device has a larger contact area. The adhesive, skin contact surface, for both the predicate and subject device utilize a | | Attributes | Subject Device | Predicate Device | Comments | | Skin Contact Material | Silicone Sensor Dressing skin adhesive material | • Patient Sensor Skin Adhesive Material | medical grade adhesive. Same | | | | | | | Body Non-Skin Contact Material | Foam Pressure Sensor Pocket for containing sensor | • Thermoplastic vulcanizate Sensor Cover | Different Subject device allows sensor cover (dressing) to be changed as necessary. Refer to the Discussion of Technological Differences (Section 8), Body Non-skin Contact Material. | | | | | | | System Configuration | The PRESSUREALERT® Pressure Monitoring System is comprised of: • PRESSUREALERT® (Patient) Pressure Sensors (round or oval) • PRESSUREALERT® Oval Segmented Dressings (for use with oval sensors) • PRESSUREALERT® Round Dressings (for use with round sensors) • PRESSUREALERT® Sacral Dressings (for use with round sensors) • PRESSUREALERT® Management Software (Medical Application for Facilities' User Interface (Android Tablet) and Network Server Software (Web- portal and Cloud- based secure data storage) | The Leaf Patient Monitoring System is comprised of: • Leaf Patient Sensors • Leaf Relay Antennas • Leaf USB Transceiver(s) (Mesh network) Leaf Patient Monitoring Software and User Interface that can be viewed on a monitoring station. | Similar technology for Primary Predicate in the use of a sensor(s) that are wireless, lithium battery operated, utilize RF wireless technology for data transfer, incorporate a user interface for monitoring, data storage, remote access to patients' data and report configuration. Refer to Discussion of Technological Differences in (Section 8), Body Site Location and Mechanism of Use. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |…

PRESSUREALERT® Pressure Monitoring System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Indications for Use

Device Story

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Submission Summary (Full Text)

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