(269 days)
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 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.
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
The Walgreen Health Solutions, LLC's PRESSUREALERT® Pressure Monitoring System did not perform any clinical studies. All acceptance criteria were met through non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Device Performance |
|---|---|
| Ingress Protection (IP4X 1mm Sphere Test) | Pass |
| Ingress Protection (IPX7 Temporary Water Immersion Test) | Pass |
| Drop Test (Functionality & Visual Damage) | Pass |
| Battery Life (Maximum Storage) | Pass (1 year) |
| Battery Life (Activated Operating) | Pass (25 days) |
| Pressure Sensor Performance (Activation Pressure Threshold) | Attained 32 mmHg (equivalent to 43.5 g/cm²) |
2. Sample Size Used for the Test Set and Data Provenance
Since only non-clinical bench tests were performed, there was no "test set" in the context of patient data. The tests were likely performed on a sample of the manufactured devices. The document does not specify the exact number of devices or components used for each bench test.
- Data Provenance: Not applicable as no human-subject data was used. All testing was non-clinical and conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for non-clinical bench testing is established by engineering specifications, regulatory standards, and objective measurements, not by expert consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. As no clinical studies were performed, there was no need for adjudication of patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No clinical studies, including MRMC studies, were conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware and software system that provides alerts to healthcare providers. While the sensors and software operate autonomously to detect pressure and generate alerts, the overall system is designed to be human-in-the-loop as it aids healthcare providers in executing turn management plans. There wasn't a separate "algorithm only" performance evaluation presented in the context of clinical outcomes. The non-clinical tests evaluate the physical and electronic performance of the components.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" was based on:
- Engineering specifications: For physical attributes like ingress protection and drop resistance.
- Performance standards: For battery life and pressure threshold (32 mmHg is a physiological threshold related to capillary pressure).
- Objective measurements: Performed during the bench testing.
8. The Sample Size for the Training Set
Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the typical sense for image analysis or diagnostic algorithms. The software appears to be rule-based for pressure detection and alerting.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was explicitly mentioned or used in this submission.
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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"
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(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
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OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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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510(k) Summary K233096
| Name: | Walgreen Health Solutions, LLC |
|---|---|
| Address: | 1316 Sherman AvenueEvanston, Illinois 60201 |
| Telephone:Fax: | 847-328-9540847-328-7950 |
| Contact Person: | Dawn BollesRegulatory 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 | |
|---|---|---|---|---|
| PrimaryPredicate | Leaf HealthcareIncorporated | Leaf PatientMonitoringSystem | 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
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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.
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7. Predicate Product Comparison Table
| Attributes | Subject Device | Predicate Device | Comments |
|---|---|---|---|
| 510(k) Number | K233096 | K141877 | |
| Device Name | PRESSUREALERT®Pressure Monitoring System | Leaf® Patient MonitoringSystem | |
| Manufacturer | Walgreen Health Solutions,LLC | Leaf Healthcare, Inc. | |
| Class | Class I | Class I | Same |
| ClassificationRegulation | 21 CFR §880.2400 | 21 CFR §880.2400 | Same |
| RegulationName | Bed-Patient Monitor | Bed-Patient Monitor | Same |
| Indications forUse | The PRESSUREALERT®Pressure Monitoring Systemmonitors the activity ofpatients who are susceptible topressure ulcers by measuringpressure at various points ofthe body. It allows healthcareproviders to execute anindividualized turnmanagement plan for eachpatient by continuouslymonitoring pressure on variouspoints of the body of eachpatient. ThePRESSUREALERT® PressureMonitoring System providesalerts when patient activitydeviates from the pressureprevention parameters set forby the healthcare providers.The device is intended for usein medical, nursing, and long-term care facilities includingindependent living, assistedliving, and rehabilitationfacilities. | The Leaf PatientMonitoring Systemmonitors the orientationand activity of patientssusceptible to pressureulcers. It allowshealthcare providers toimplement individualizedturn management plansand continuously monitoreach patient. The LeafPatient MonitoringSystem provides alertswhen patient orientationor activity deviates fromparameters set byhealthcare providers. Thedevice is intended for usein medical, nursing, andlong-term care facilities,including independentliving, assisted-living andrehabilitation facilities. | Similar for use in theprevention of pressureulcer formation andexecution ofindividualized turnmanagement patientplans. The subjectdevice can be placedon multiple parts ofthe body as comparedto the predicate devicewhich is placed inonly 1 location asdescribed in (Section8) The Discussion ofTechnologicalDifferences, Body SiteLocation and thedifferences raises nonew issues of safetyand effectiveness. |
| Principle ofOperation | Wearable pressure sensor(inserted into a dressing andattached to patients' skin)functions to providemonitoring of selected "atrisk" body locations and alarmif meets pressure levelthresholds related to pressureulcer formation. Table pressure | Wearable sensor attachedto patients' skin and adisplay monitor for turnstatus and alerts.Wearable sensor thatprovides reminders andtracking of patientrepositioning and turningin order to prevent | Similar, supportspatient repositioningprotocol. TheDiscussion ofTechnologicalDifferences (Section8), Body SiteLocation, refers to thedifferences in the |
| Attributes | Subject Device | Predicate Device | Comments |
| different pressure and alarmwhen threshold met. Bedsidetablet and remote monitoringprovide reporting on pressureevents and repositioningreporting to support effectivepatient repositioning protocol. | subject deviceoperations and raisesno new issues ofsafety andeffectiveness. | ||
| IntendedPopulation | The PRESSUREALERT®Pressure Monitoring System isnot intended for use withpatients under the age of 18,pregnant women, or themorbidly obese (Class 3, BMI40 or greater). Safe use forpatients under the age of 18,pregnant women, and themorbidly obese has not beenestablished. | The Leaf PatientMonitoring System hasnot been tested on womenwho are pregnant orbreastfeeding, so the risksto unborn fetuses andnursing children areunknown. Safety andeffectiveness for use bypregnant women andchildren (under the age of18) has not beenestablished. | Similar, the predicatedevice indication doesnot include themorbidly obesepotentially due to theplacement location onthe patient (single site,chest). The subjectdevice can be utilizedon up to 11 body sitelocations and themorbidly obeserequire specialrepositioning protocol,staff, and equipmentthat could interferewith the sensor. Thiscontraindication raisesno new issues ofsafety andeffectiveness. |
| Intended UseEnvironment | The device is for use inprofessional healthcarefacilities only includingindependent living, assistedliving, and rehabilitationfacilities. | The device is intended foruse in medical, nursing,and long-term carefacilities, includingindependent living,assisted living, andrehabilitation facilities. | Same |
| Prescription | Yes | Yes | Same |
| Single Use | Sensor Dressing Only (SensorNo) | No | Same |
| Sterile | No | No | Same |
| Single Patient –Multiple Use | Sensor Only | Yes (on label of Sensor) | Same |
| Sensor Size | Round Sensor - placed inround or sacral dressing foampocket:Oval Sensor - placed into ovalsegmented dressing foampocket: | Sensor Single 1.8" x2.0", | The subject device hasa larger contact area.The adhesive, skincontact surface, forboth the predicate andsubject device utilize a |
| Attributes | Subject Device | Predicate Device | Comments |
| Skin ContactMaterial | Silicone Sensor Dressing skinadhesive material | • Patient Sensor SkinAdhesive Material | medical gradeadhesive.Same |
| Body Non-SkinContact Material | Foam Pressure Sensor Pocketfor containing sensor | • Thermoplasticvulcanizate SensorCover | Different Subjectdevice allows sensorcover (dressing) to bechanged as necessary.Refer to theDiscussion ofTechnologicalDifferences (Section8), Body Non-skinContact Material. |
| SystemConfiguration | The PRESSUREALERT®Pressure Monitoring System iscomprised of:• PRESSUREALERT®(Patient) Pressure Sensors(round or oval)• PRESSUREALERT®Oval Segmented Dressings(for use with oval sensors)• PRESSUREALERT®Round Dressings (for usewith round sensors)• PRESSUREALERT®Sacral Dressings (for usewith round sensors)• PRESSUREALERT®Management Software(Medical Application forFacilities' User Interface(Android Tablet) andNetwork Server Software(Web- portal and Cloud-based secure data storage) | The Leaf PatientMonitoring System iscomprised of:• Leaf Patient Sensors• Leaf RelayAntennas• Leaf USBTransceiver(s)(Mesh network)Leaf Patient MonitoringSoftware and UserInterface that can beviewed on a monitoringstation. | Similar technology forPrimary Predicate inthe use of a sensor(s)that are wireless,lithium batteryoperated, utilize RFwireless technologyfor data transfer,incorporate a userinterface formonitoring, datastorage, remote accessto patients' data andreport configuration.Refer to Discussion ofTechnologicalDifferences in(Section 8), Body SiteLocation andMechanism of Use. |
| Patient SensorPower source | Internally Powered | Internally Powered | Same |
| Patient SensorWirelessTransmissionFrequency | 2.4 GHz | 2.4 GHz | Same |
| ElectricalVoltage –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 evaluatedimmediately by thepatient's doctor or othermember of their careteam. | adhesive used in thesubject device. | ||
| ProductStability/Life ofthe Device | Sensor – up to 25 daysafter activation. 1-year ifnot activated.Dressings – 2-years if packageunopened or adhesive notexposed. | The Leaf PatientSensor is designedto work until thebattery is depleted,which is typically upto 21 days.The device isdesigned for singlepatient multiple use.If the sensor needsto be removed froma patient temporarilyfollow instructionson “Removing theLeaf PatientSensor”, to reapplythe sensor followinstructions for “Re-Applying the PatientSensor.There are no partsthat need to bereplaced. ThePatient Sensor isworking properly ifit functions asdescribed in thisbooklet. | Leaf andPRESSUREALERT®activated battery lifewithin a similar rangeof 21 to 25 days asdescribed in theDiscussion ofTechnologicalDifferences (Section8), Battery Life. |
| Report Data | The following options areavailable:Report type:• Patient Info• Pressure Ulcer status(optional data report)• Events status (Pressureevents)• Reposition status(Turning protocolreporting and pressurerelief reporting)• Alarm Response statusPatient information:• Required (MRN) | • Report GeneratedDate and time.• Patient Information(Patient Name, firstand last, MRN, startdate, end date,patient status, unit,room)• Turning protocolsettings• Summary of turns,monitoring time,time upright, timeprone, patientmovementTotal time on left, back, | General patientinformation input –same.• Leaf reports, andsubject device canmonitor patientturning /repositioning.• Subject device canalso report additionalpressure eventsoutside of thefacility standardturning 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. |
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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.
§ 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.