(269 days)
No
The summary describes a system that monitors pressure and provides alerts based on predetermined levels set by healthcare providers. There is no mention of AI or ML being used for analysis, prediction, or learning from data. The system appears to be based on simple threshold-based alerting.
No.
The device is a monitoring system designed to alert healthcare providers to high-pressure areas to prevent pressure ulcers, rather than actively treating a medical condition.
Yes
The device monitors pressure at various body points and provides alerts when activity deviates from set parameters designed to prevent pressure ulcers, indicating it identifies conditions that may lead to a medical problem.
No
The device description explicitly states that the system is composed of a "wireless pressure sensing dressing assembly" and lists physical components like "PRESSUREALERT® Segmented Oval Dressing", "PRESSUREALERT® Round Dressing", "PRESSUREALERT® Sacral Dressing", "PRESSUREALERT® Oval Sensor", and "PRESSUREALERT® Round Sensor". These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PRESSUREALERT® Pressure Monitoring System directly monitors pressure on the patient's body surface. It does not analyze any biological specimens.
- Intended Use: The intended use is to monitor patient activity and pressure points to help prevent pressure ulcers, not to diagnose a condition based on laboratory analysis of a specimen.
The device is a non-invasive monitoring system that interacts with the patient's external body surface.
N/A
Intended Use / Indications for Use
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.
Product codes
SBO
Device 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 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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
Indicated Patient Age Range
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.
Intended User / Care Setting
The device is intended for use in 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
There were no clinical studies conducted.
Non-clinical testing included Ingress protection testing, drop testing, and battery life testing.
Ingress protection testing:
- IP4X 1 mm Sphere test resulted in "Pass".
- IPX7 temporary water immersion test resulted in "Pass".
Drop test: "Pass", no visual signs of damage, and functionality parameters met.
Battery life test: "Pass" for a calculated maximum storage battery life of 1 year and an activated operating life of 25 days. Battery life parameters based on a maximum storage temperature of +70°C and an activated battery operating temperature range of +5°C to +40°C.
Pressure Sensor Performance Testing (Activation Pressure Test): The sensor attained the required threshold of 32 mmHg (equivalent to 43.5 g/cm²).
Software verification was also conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- |
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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 |
- 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 - 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. |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Patient Sensor
Power source | Internally Powered | Internally Powered | Same |
| | | | |
| Patient Sensor
Wireless
Transmission
Frequency | 2.4 GHz | 2.4 GHz | Same |
| | | | |
| Electrical
Voltage –
Power Supply
(Patient Sensor) | 3 VDC | 3 VDC | Same |
| | | | |
| Attributes | Subject Device | Predicate Device | Comments |
| Patient Sensor Applied Part Type | Patient Sensor Applied Part Type BF | Patient Sensor Applied Part Type CF | Similar, CF based on location over heart (cardiac application), the subject device is not placed directly over the heart. The subject device can be placed up to 11 locations as discussed in the Discussion of Technological Differences (Section 8), Body Site Location (there are 11 locations including: left/right hips, left/right ischium (buttocks), left/right heels, skull, upper spine prominence, left/right elbows, and sacrum (tailbone)) and is not located over the heart. This difference raises no new issues of safety and effectiveness. |
| Electromagnetic Emissions | Compliant with Part 15 of FCC Rules | Compliant with Part 15 of FCC Rules | Same |
| Alerts | Yes | Yes | Same |
| Patient Sensor Wireless Transmission Protocol | Utilizes wireless technology. | Utilize wireless technology. | Same |
| Biocompatibility (Silicone Foam Dressing) un-breached skin only | ISO 10993-1 | Though the silicone adhesive material used in the Leaf Patient Sensor is commonly used in other healthcare products and has a well-established safety profile, an allergic reaction to the adhesive is possible. If a patient experiences a rash, skin redness, itching, or swelling in the area where the Leaf Patient Sensor was applied, this may be a sign of an | Same, both the subject device and primary predicate use a silicone adhesive material (skin contact) commonly used in the healthcare industry as described in the Discussion of Technological Differences, (Section 8), Body Non-skin Contact Material. Biocompatibility data is available for |
| Attributes | Subject Device | Predicate Device | Comments |
| | | should be evaluated
immediately by the
patient's doctor or other
member of their care
team. | adhesive used in the
subject device. |
| Product
Stability/Life of
the Device | Sensor – up to 25 days
after activation. 1-year if
not activated.
Dressings – 2-years if package
unopened or adhesive not
exposed. | The Leaf Patient
Sensor is designed
to work until the
battery is depleted,
which is typically up
to 21 days.
The device is
designed for single
patient multiple use.
If the sensor needs
to be removed from
a patient temporarily
follow instructions
on “Removing the
Leaf Patient
Sensor”, to reapply
the sensor follow
instructions for “Re-
Applying the Patient
Sensor.
There are no parts
that need to be
replaced. The
Patient Sensor is
working properly if
it functions as
described in this
booklet. | Leaf and
PRESSUREALERT®
activated battery life
within a similar range
of 21 to 25 days as
described in the
Discussion of
Technological
Differences (Section
8), Battery Life. |
| Report Data | The following options are
available:
Report type:
• Patient Info
• Pressure Ulcer status
(optional data report)
• Events status (Pressure
events)
• Reposition status
(Turning protocol
reporting and pressure
relief reporting)
• Alarm Response status
Patient information:
• Required (MRN) | • Report Generated
Date and time.
• Patient Information
(Patient Name, first
and last, MRN, start
date, end date,
patient status, unit,
room)
• Turning protocol
settings
• Summary of turns,
monitoring time,
time upright, time
prone, patient
movement
Total time on left, back, | General patient
information input –
same.
• Leaf reports, and
subject device can
monitor patient
turning /
repositioning.
• Subject device can
also report additional
pressure events
outside of the
facility standard
turning protocol at |
| Attributes | Subject Device | Predicate Device | Comments |
| | Patient First and Last Name, Age, Gender, existing Pressure Injuries, and location are all optional information. Sensor(s) serial number and location on patient. | right, left upright, back upright, right upright, left semi prone, prone, right semi prone. | specific at- risk locations. In the Discussion of Technological Differences (Section 8), Body Site Location, the subject device monitors pressure between standard turning protocol. |
7
8
9
10
11
12
8. Discussion of Technological Differences
Body Site Location – Location for the predicate device is a single location (chest). The subject device can be located on 11 different areas of the body and can report repositioning data. This difference raises no new issues of safety and effectiveness because of verification and validation of the software. The subject device detects activity via pressure changes; the predicate device detects activity via orientation changes with an accelerometer.
Mechanism of Use - The subject device, unlike the predicate, does not utilize USB relay / antennas mesh network with antenna. The subject device incorporates the latest wireless technology to accomplish the same data transfer and raises no new issues of safety and effectiveness.
Sensor Size - The subject device has a larger contact area compared to the predicate device, but the adhesive used in both devices is a medical grade commonly used in medical dressing. The sensor size difference raises no new issues of safety and effectiveness.
Non-skin Contact Material – Both the subject device and the predicate device provide a patient non-contact sensor by encapsulating the sensor inside a covered component that is attached to the patient's skin by use of a medical grade adhesive commonly used in medical dressings. The subject device non-contact sensor can be removed from the dressing to change the dressing as needed whereas the predicate sensor is sealed. The sensor non-skin contact differences raises no new issues of safety and effectiveness.
Battery Life - The subject sensor battery life, once activated, can be used up to 25 days and 1 year if not activated. The predicate sensor battery life, once activated, can be used up to 21 days, The difference between sensor battery life of the predicate and subject device 21 days and 25 days once activated raises no new issues of safety and effectiveness.
Non-Clinical Test Result Summary
The Product Comparison discussions of the technological differences, and the conclusions the non-clinical testing; those results demonstrate that drawn from the PRESSUREALERT® Pressure Monitoring System is substantially equivalent to the predicate device. Non-clinical testing included Ingress protection testing, drop testing, and battery life testing. Regarding the Ingress protection testing, the tests performed on the PRESSUREALERT® Pressure Sensors and Pressure Sensor Dressings included the IP4X 1 mm Sphere test and the IPX7 temporary water immersion test. There were no unexpected results, and the results of both tests were a "Pass".
The drop test required that the PRESSUREALERT® Pressure Sensors pass the
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functionality parameters and have no visual signs of damage. Again, there were no unexpected results, and the test was given a "Pass". The battery life test for the Sensor's Lithium battery was performed and there were no unexpected results, and the sensor has a "Pass" for a calculated maximum storage battery life of 1 year and an activated operating life of 25 days. The battery life parameters were based on a maximum storage temperature of +70°C and an activated battery operating temperature range of +5°C to +40°C. The use of the worst-case temperature scenario was determined to be the basis for the recommended operating use and storage life. Finally, the third party non-clinical testing has shown that after extensive pressure sensor performance (activation pressure test) testing, the PRESSUREALERT® Pressure Monitoring System sensor attained the required threshold of 32 mmHg (equivalent to 43.5 g/cm²).
9. Non-clinical Testing
- . IEC 60601-1-2:2014+A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- CISPR 11:2015+A1:2016+A2:2019 Limits and methods of measurement of o radio disturbance, Characteristics of industrial, scientific, and medical radio frequency equipment
- IEC 61000-4-2:2008 Electromagnetic Compatibility-Part 4: Testing and O measurement techniques - Section 2: Electrostatic discharge immunity test
- IEC 61000-4-3:2010 Electromagnetic Compatibility-Part 4: Testing and O measurement techniques - Section 3: Radiated, radiofrequency, electromagnetic field immunity test.
- IEC 61000-4-8:2009 Electromagnetic Compatibility-Part 4: Testing and o measurement techniques - Section 8: Power frequency magnetic field immunity test
- IEEE/ANSI C63.27-2021 American National Standard for Evaluation of Wireless ● Coexistence
- AAMI TIR69 2017(R2020) Risk management of radio-frequency wireless ● coexistence for medical devices and systems
- . AIM 7351731 Rev. 3.00 (2021-06-04) – Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
- FDA Guidance Document Electromagnetic Compatibility (EMC) of Medical . Devices (June 6, 2022) - Section J - Common Electromagnetic (EM) Emitters
- . IEC TR 60601-4-2:2016 - Medical electrical equipment -- Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
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- IEC 62304:2006/A1:2006 Medical device software Software life cycle processes -● Medical Equipment Process Standard
- ISO 14971:2007+2019 Medical devices Application of risk management to ● medical devices - Medical Equipment Management Standard.
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process.
- . ISO 10993-5 Biological evaluation of medical devices – Part 5 Tests for in vitro (cytotoxicity)
- ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for Irritation ● and Sensitization
In addition, the following system performance bench tests were conducted:
- Software verification o
- Ingress Protection Testing O
- Drop Tests o
- Batterv Life o
- Pressure Sensor Performance Testing (Activation Pressure Test) o
10. Clinical Studies
There were no clinical studies conducted.
11. Conclusion
Based on the Product Comparison Table (Section 7) and the discussions of the technological differences and non-clinical testing, the results demonstrate the PRESSUREALERT® Pressure Monitoring System is substantially equivalent to the predicate to assist in effective patient turning protocol and aid in the prevention of pressure ulcers.