iBed Wireless with iBed Mobile

K202964 · Stryker Corporation · FNL · Jun 18, 2021 · General Hospital

Device Facts

• Record ID: K202964
• Device Name: iBed Wireless with iBed Mobile
• Applicant: Stryker Corporation
• Product Code: FNL · General Hospital
• Decision Date: Jun 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5100
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization's campus. The iBed™ Wireless with iBed™ accessory is intended to be used only with Stryker Medical's AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

Device Story

iBed Wireless with iBed Mobile is a software accessory for Stryker AC-powered adjustable hospital beds; enables bi-directional data transmission between the bed, a healthcare organization's server, and a mobile device. Input: bed status/parameters (e.g., height, siderail position, head angle, brake status, bed exit sensitivity). Transformation: WiFi module (IEEE 802.11 a/b/g/n/ac) transmits data to/from the server and mobile application. Output: remote monitoring and control of bed settings via mobile GUI. Used in healthcare facilities by healthcare professionals. Does not store patient data; does not provide automated treatment decisions. Benefits: allows remote management of bed parameters, improving workflow efficiency for clinicians.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including software verification, bench performance, and design validation in simulated-use environments.

Technological Characteristics

System includes WiFi module (IEEE 802.11 a/b/g/n/ac) and mobile software. Operates on Apple iOS 14+. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-52, IEC 62304, IEEE 802.11, AAMI TIR69, NIST SP 800-53. Bi-directional data transmission. Cybersecurity controls included.

Indications for Use

Indicated for patients confined to a healthcare delivery organization bed. Intended for use by healthcare professionals to set, adjust, and monitor bed parameters remotely within the facility.

Regulatory Classification

Identification

An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• iBed™ Wireless with iBed™ Awareness (K103536)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.

June 18, 2021

Stryker Corporation Cathy Friday Sr. Staff Regulatory Affairs Specialist 3800 E. Centre Avenue Portage, Michigan 49002

Re: K202964

Trade/Device Name: iBed Wireless with iBed Mobile Regulation Number: 21 CFR 880.5100 Regulation Name: AC-Powered Adjustable Hospital Bed Regulatory Class: Class II Product Code: FNL Dated: May 13, 2021 Received: May 17, 2021

Dear Cathy Friday:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K202964

Device Name iBed™ Wireless with iBed™ Mobile

#### Indications for Use (Describe)

The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization's campus. The iBed™ Wireless with iBed™ accessory is intended to be used only with Stryker Medical's ACpowered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Mireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# Traditional 510(k) Summary K202964

# I. SUBMITTER

Stryker Medical 3800 E. Centre Ave Portage, MI 49002

Cathy Friday Sr. Staff Regulatory Affairs Specialist e: [e-mail] t: [phone]

Date of Summary: 13 May 2021

# II. SUBJECT DEVICE

| Device Trade or<br>Proprietary Name: | iBed™ Wireless with iBed™ Mobile<br>Model 5212 |
|--------------------------------------|------------------------------------------------|
| Common or Usual Name: | AC-Powered Adjustable Hospital Bed (Accessory |
| Regulation Number: | 21 CFR 880.5100, 510(k) Exempt |
| Classification Name: | AC-Powered Adjustable Hospital Bed |
| Product Code: | FNL |
| Class: | Class II |
| Review Panel: | General Hospital |

#### III. PREDICATE DEVICE

iBedTM Wireless with iBed™ Awareness, K103536 (Stryker Corporation)

#### IV. DEVICE DESCRIPTION

The Model 5212 iBed™ Wireless with iBed™ Mobile consists of iBed™ Wireless (WiFi module) and the iBed™ Mobile software application that is intended to be used with Stryker Medical's ACpowered adjustable hospital beds within a healthcare delivery organization. The iBed™ Wireless with iBed™ Mobile device accessory is an updated software platform that provides bi-directional data transmission between Stryker Medical's AC-powered adjustable hospital beds equipped with iBed™ Wireless, the healthcare delivery organization's server (owned and maintained by the healthcare delivery organization), and a healthcare professional's handheld electronic device. It is a convenience tool facilitating bi-directional data transmission of bed status data and parameters allowing healthcare professionals the ability to set, adjust, and monitor bed status from a remote

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location within the healthcare delivery organization facility. Table 1 provides an overview of the specific bed parameters utilized by the iBed™ Wireless with iBed™ Mobile device accessory.

As a security measure, the iBed™ Wireless with iBed™ Mobile device accessory is only available to healthcare professionals connected to their healthcare delivery organization's information system network and is not accessible or operational by the public. The iBed™ Wireless with iBed™ Mobile device is intended to only transfer bed status and parameter data and does not store this data. All bed functions and parameters remain available at bedside.

The iBed™ Wireless with iBed™ Mobile device accessory is not intended to provide automated treatment decisions or be used as a substitute for professional healthcare judgement.

Image /page/4/Figure/3 description: The image shows a diagram of a hospital network. The network includes third-party systems, iBed Mobile on a user device, and iBed Wireless with a WiFi module on the bed. The diagram illustrates the connection between the hospital network and the iBed devices.

Figure 1: iBed™ Wireless with iBed™ Mobile System

iBed™ Wireless with iBed™ Mobile Device Accessory Components

# iBed™ Watch

When enabled, iBed™ Watch provides visual cues when changes are made to the selected bed settings: low height, siderails up, head (back rest) angle, bed exit zone, and bed flat. Note: The iBed™ Watch function was previously marketed as iBed™ Awareness and cleared under the predicate device 510(k) submission (K103536).

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#### iBed™ Wireless (WiFi Module)

The iBed™ Wireless software and hardware system used in Stryker Medical beds enabled with iBed™ Watch allows remote viewing of bed status. The WiFi radio containing the iBed™ Wireless software allows bi-directional data transmissions from the healthcare delivery organization's central Information Systems server and the Stryker Medical bed. A healthcare professional can set, adjust, and monitor bed status parameters from a non-bedside location within the healthcare delivery organizations facility.

# iBed™ Mobile

The iBed™ Mobile application is a convenience tool that allows a healthcare professional the ability to set, adjust, and/or monitor bed status parameters from a non-bedside location anywhere within the healthcare delivery organizations facility. The iBed™ Mobile device accessory can only function with Stryker Medical beds enabled with iBed™ Wireless software. The iBed™ Mobile application run on Apple iOS Revision 14 or greater operating system. Note: All bed functions remain usable at bedside when using the iBed™ Mobile device accessory.

Viewing and/or enabling of specific bed parameters can be conducted from a mobile device using iBed™ Mobile. Stryker Medical will upload iBed™ Mobile software upgrades to relevant mobile application stores to be downloaded by the user. Upgrades will be sent to the Stryker Medical bed via the iBed™ Platform and iBed™ Wireless where the healthcare professional will have to accept the upgrade at bedside to download the update. Table 1 contains a list of the StrykerMedical Bed parameters that can be managed using iBed™ Wireless with iBed™ Mobile.

Image /page/5/Figure/5 description: The image shows a screenshot of a medical device application. The application displays patient information, including the patient ID "7094" and fall risk level "LOW FALL RISK". The application also shows various settings and features, such as bed height, nurse call, brake, motion lock, iBed Watch, and bed alarm sensitivity. The bed alarm sensitivity can be adjusted for falls, rounding, skin, and scale.

Figure 2: iBed™ Mobile Room View Screen Explanation

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| | iBed™ Mobile Function | Status | Parameter Description |
|---|----------------------------|-------------|-----------------------------------------------------------------------------------------------------------|
| A | Location/Patient<br>Status | View Only | Displays room location, patient fall risk, and<br>bed protocol notifications, bed serial number |
| B | Bed Status | View only | Displays HOB >30, bed height, nurse call<br>connected, brake, siderail position, bed exit<br>sensitivity. |
| C | Motion Lock | Enable only | Locks bed motion. |
| D | Bed Exit | Enable only | Activate and select bed exit sensitivity. |
| E | iBed™ Watch | Enable only | Activates iBed™ Watch. |
| F | Falls | View only | Displays falls tab (Falls tab) |
| G | Rounding | View only | Displays rounding tab (Rounding tab) |
| H | Skin | View only | Displays skin tab (Skin tab) |
| I | Scale | View only | Displays scale tab (Scale tab) |

Table 1: Bed Status Parameters Using iBed™ Mobile

# V. INTENDED USE STATEMENT

The intended use of the iBed™ Wireless with iBed™ Mobile accessory is to assist healthcare professionals in setting, adjusting, and monitoring specific bed parameters from a different location within the healthcare delivery organization's campus. The iBed™ Wireless with iBed™ Mobile accessory is intended to be used only with Stryker Medical's AC-powered adjustable hospital beds that have been verified and validated with the iBed™ Wireless software and is not intended to provide information on non-Stryker Medical beds. The iBed™ Wireless with iBed™ Mobile accessory is intended to only transfer bed status and parameter data and does not store this data.

#### VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Design verification and validation testing was performed on the iBed™ Wireless with iBed™ Mobile and included software verification, bench performance, and design validation. Software verification testing was conducted to ensure the bi-directional capability performed according to specification. Bench performance testing was conducted to ensure the bed software, firmware, and iBed™ Mobile performed together according to specification. Design validation testing was conducted in a simulated-use environment by health care professionals. Users were successfully able to set, adjust, and monitor bed status parameters from remote locations within the healthcare delivery organization as intended.

Note: In the following table, the "Subject Device" is defined as the iBed™ Wireless with iBed™ Mobile device and the "Predicate Device" is defined as the iBed™ Wireless with iBed™ Awareness (K103536).

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| | Subject Device<br>iBed™ Wireless with iBed™ | Predicate Device<br>iBed™ Wireless with iBed™ | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Characteristic | Mobile (K202964) | Awareness (K103536) | Differences |
| Device Trade or<br>Proprietary Name | iBed™ Wireless with iBed™<br>Mobile | iBed™ Wireless with iBed™<br>Awareness | Addition of iBed™ Mobile<br>iBed™ Awareness was<br>renamed iBed™ Watch. |
| Product Model Number | 5212 | Same | None |
| Common or Usual Name | AC-Powered Adjustable<br>Hospital Bed (Accessory) | Same | None |
| Regulation Number | 21 CFR 880.5100<br>510(k) Exempt | Same | None |
| Classification Name | AC-Powered Adjustable<br>Hospital Bed | Same | None |
| Product Code | FNL | Same | None |
| Class | Class II | Same | None |
| Review Panel | General Hospital | Same | None |
| Intended Use | The iBed™ Wireless with<br>iBed™ Mobile device<br>accessory's intended use is to<br>provide healthcare professionals<br>the ability to set, adjust, and<br>monitor specific bed parameters<br>from a remote location within a<br>healthcare delivery | The intended use for the iBed™<br>Wireless with iBed™<br>Awareness is to assist clinical<br>staff to monitor bed parameters<br>on specific Stryker Medical<br>beds. The monitored<br>parameters include bed brakes,<br>side rail position, bed exit, etc. | Subject device can set, adjust,<br>and monitor specific bed status<br>parameters. Predicate device<br>can only monitor bed status.<br>The Intended Use statement for<br>the iBed™ Wireless with<br>iBed™ Mobile device isnot<br>identical to the predicate |

| Table 2: Comparison of Technological Characteristics with the Predicate Device | | | | |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Subject Device<br>iBed™ Wireless with iBed™ | Predicate Device<br>iBed™ Wireless with iBed™ | | |
| Device Characteristic | Mobile (K202964) | Awareness (K103536) | Differences | |
| | organization's facility using bi-<br>directional data communication.<br>The desired bed parameters will<br>be initially set by healthcare<br>professionals at bedside. The<br>iBed™ Wireless with iBed™<br>Mobile device accessory is<br>intended to be used only with<br>specifically enabled Stryker<br>beds that have been verified and<br>validated with the iBed®<br>Wireless software and is not<br>intended to provide bed status<br>information for non-Stryker<br>beds. Patient health<br>information is not<br>communicated or stored. | The desired bed parameters will<br>be set by clinicians at the<br>bedside. The iBed™ Wireless<br>software is intended to be used<br>only with specifically enabled<br>Stryker Medical beds that have<br>been verified and validated with<br>the iBed™ Wireless software<br>and is not intended to provide<br>bed status information for non-<br>Stryker Medical beds. The<br>iBed™ Wireless software is not<br>intended to communicate any<br>patient status information nor to<br>permanently store any type of<br>data. | device; however, the<br>differences do not alter the<br>intended use of the device nor<br>do they affect the safety and<br>effectiveness of the device<br>relative to the predicate. Both<br>the subject and predicate<br>devices have the same intended<br>use for the ability to monitor the<br>patient's bed parameters, either<br>from a stationary nurse station<br>as in the predicate device or via<br>the mobile application in the<br>subject device. | |
| Indications for Use | The intended patient population<br>is dependent on the Stryker<br>Medical bed location within the<br>healthcare delivery<br>organization. The iBed™<br>Wireless with iBed™ Mobile<br>accessory does not change the<br>existing populations for which<br>these beds serve. | Same | None | |
| Device Characteristic | Subject Device<br>iBed™ Wireless with iBed™<br>Mobile (K202964) | Predicate Device<br>iBed™ Wireless with iBed™<br>Awareness (K103536) | Differences | |
| Primary Function | Bi-directional data<br>communication for activating or<br>viewing bed status parameters. | One-way data communication<br>for viewing bed status<br>parameters. | Subject device utilizes bi-<br>directional data transmission<br>that allow remote activation and<br>viewing. | |
| Intended Patient<br>Population | Patients confined to a<br>healthcare delivery organization<br>bed (not for use in a home or<br>non-institutional long-term care<br>facility setting). | Same | None | |
| Intended Users | Healthcare Professionals | Same | None | |
| Operational Environment | Must be used in a healthcare<br>delivery organization. | Same | None | |
| Bed Status Parameters -<br>Location/Status | • Remote viewing of:<br>o Room location<br>o Patient fallrisk<br>o Bed protocol<br>notifications<br>o Bed serial number | • Remote viewing of:<br>o Room location | Subject device added remote<br>viewing of patient fall risk, bed<br>protocol notifications, and bed<br>serial number. | |
| Device Characteristic | Subject Device<br>iBed™ Wireless with iBed™<br>Mobile (K202964) | Predicate Device<br>iBed™ Wireless with iBed™<br>Awareness (K103536) | Differences | |
| Bed Status Parameters -<br>Bed Status | • Monitoring of:<br>o HOB angle >30<br>o Bed height<br>o Nurse call connected<br>o Brake (locked/unlocked)<br>o Siderail position<br>o Bed exit zone and<br>sensitivity | Same | None | |
| Bed Status Parameters -<br>Bed Motion | • Bedside and remote locking<br>of bed motion<br>• Bedside and remote<br>monitoring of bed exit<br>sensitivity | • Bedside locking of bed<br>motion<br>• Bedside and remote<br>monitoring of bed exit<br>sensitivity | Remote activation using Subject<br>device. | |
| Bed Status Parameters -<br>Bed Exit | • Bedside and remote<br>activation<br>• Bedside and remote status<br>monitoring | • Bedside activation<br>• Bedside and remote status<br>monitoring | Remote activation using Subject<br>device. | |
| Bed Status Parameters -<br>Bed and Patient Position<br>Monitoring | • iBed™ Watch | • iBed™ Awareness | None. iBed™ Awareness was<br>renamed as iBed™ Watch. | |
| Bed Status Parameters -<br>Patient Fall Risk | • Displays assessment and<br>score | • Not available | Subject device function only. | |
| Bed Status Parameters -<br>Rounding | • Displays assessment and<br>score | • Not available. | Subject device function only. | |
| Device Characteristic | Subject Device<br>iBed™ Wireless with iBed™<br>Mobile (K202964) | Predicate Device<br>iBed™ Wireless with iBed™<br>Awareness (K103536) | Differences | |
| Bed Status Parameters –<br>Support Surface Settings<br>(if available) | • Remote display of<br>assessment and score | • Not available | Subject device function only. | |
| Bed Status Parameters –<br>Bed Scales | • Remote display of scale<br>information | Same | None | |
| Installation | 1. Configure bed for wireless<br>connection to the central<br>healthcare Delivery<br>Organization's Information<br>System network server.<br><br>2. Install iBed™ Mobile<br>application fromrelevant<br>mobile application stores<br>(i.e. Apple).<br><br>3. Configure iBed™ Mobile<br>for use. | 1. Install iBed™ Locator into<br>the room / bay.<br><br>2. Associate iBed™ Locator to<br>the healthcare delivery<br>organization's room / bay.<br>Upgrade bed software (if<br>needed).<br><br>3. Configure bed for wireless<br>connection to the private<br>healthcare delivery<br>Information System<br>network server. | Subject device requires the<br>iBed™ Mobile application to be<br>installed on handheld electronic<br>device and configured to the<br>healthcare delivery<br>organization's protocols. | |
| User Operation | 1. The healthcare professional<br>initially sets bed parameter<br>settings at bedside.<br><br>2. Data is automatically sent to<br>server and downloaded to<br>monitoring station and<br>Subject device. | 1. The healthcare professional<br>initially sets bed parameter<br>settings at bedside.<br><br>2. Data is automatically sent to<br>server and downloaded to<br>monitoring station. | Subject device provides the<br>ability to set, adjust, and<br>monitor bed status parameters<br>from remote location within the<br>healthcare delivery<br>organization. | |
| Device Characteristic | Subject Device<br>iBed™ Wireless with iBed™<br>Mobile (K202964) | Predicate Device<br>iBed™ Wireless with iBed™<br>Awareness (K103536) | Differences | |
| | 3. The healthcare professional<br>completes her/his review of<br>the bed parameters at<br>monitoring station or using<br>the iBed™ Mobile<br>application.<br>Based on healthcare<br>delivery organization<br>(HDO) protocols, the<br>healthcare professional<br>may set, adjust, and/or<br>continue monitoring bed<br>parameters. | 3. The healthcare professional<br>completes her/his review of<br>the bed parameters at<br>monitoring station.<br>4. Healthcare provider able to<br>monitor bed parameters<br>from a different location<br>within the healthcare<br>delivery organization.<br>5. If adjustments are needed,<br>the healthcare professional<br>must be bedside to make<br>them. | The Predicate device must have<br>bed adjustments made at<br>bedside and can be monitored a<br>bedside and nurse station. | |
| Primary Device Function | Bi-directional data transmission<br>of specific bed parameters<br>between HDO's central<br>Information System software<br>system. | One-way directional data<br>transmission of specific bed<br>parameters between HDO's<br>central Information System<br>software system. | Subject device utilizes bi-<br>directional data communication<br>versus the Predicate device's<br>one-way data communication. | |
| User Interface | The bed's footboard panel must<br>be used to initially set bed<br>status parameters. | Same | None | |
| | The iBed™ Mobile application<br>adds the following GUI screens:<br>● Login<br>● List View | Adjustments must be made at<br>bedside. | iBed™ Mobile | |
| Device Characteristic | Subject Device<br>iBed™ Wireless with iBed™<br>Mobile (K202964) | Predicate Device<br>iBed™ Wireless with iBed™<br>Awareness (K103536) | Differences | |
| | • Room View<br>• iBed Watch Status<br>• Falls Tab<br>• Rounding Tab<br>• Skin Tab<br>• Scale Tab | | | |
| Main System Components | • iBed™ Wireless WiFi<br>Module (Bed)<br>• Bi-directional iBed™<br>Wireless Software<br>• iBed™ Mobile<br>• iBed™ Watch | • iBed™ Wireless WiFi<br>Module (Bed)<br>• Uni-directional iBed™<br>Wireless Software<br>• iBed™ Awareness | iBed™ Mobile | |
| Wireless Communications<br>– Data Transmission | Bi-directional data<br>transmission:<br>Bed to server to iBed™ Mobile<br>to healthcare professional and<br>then back to iBed™ Mobile<br>then back to server then back to<br>bed. | Uni-directional data<br>transmission:<br>Bed to server. | Two-way data transmission<br>versus one-way data<br>transmission. | |
| Wireless Communications<br>– WiFi Radio Module | WiFi module - IEEE 802.11<br>a/b/g/n/ac (bi-directional) | WiFi module - IEEE 802.11 b/g<br>(uni-directional) | Subject device module<br>upgraded to next generation<br>radio. | |
| Device Characteristic | Subject Device<br>iBed™ Wireless with iBed™<br>Mobile (K202964) | Predicate Device<br>iBed™ Wireless with iBed™<br>Awareness (K103536)…