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.

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 location within the healthcare delivery organization facility.

AI/ML Overview

This document is a 510(k) premarket notification for the "iBed™ Wireless with iBed™ Mobile" device, focusing on demonstrating substantial equivalence to a predicate device. It does not describe a clinical study that proves the device meets specific performance acceptance criteria for diagnostic or clinical effectiveness functions in the way an AI/ML medical device submission would.

The device is an accessory to hospital beds, providing healthcare professionals the ability to remotely set, adjust, and monitor bed parameters. The key difference from the predicate device (iBed™ Wireless with iBed™ Awareness, K103536) is the addition of bi-directional communication, allowing remote adjustment of parameters, whereas the predicate only allowed remote monitoring.

Therefore, the acceptance criteria and study described are related to engineering performance, software functionality, and safety rather than a diagnostic accuracy or clinical outcome study involving human readers or AI.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) typically seen in AI/ML medical device submissions. Instead, it describes general categories of testing and their purpose:

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Software Functionality (Bi-directional Capability)	"Software verification testing was conducted to ensure the bi-directional capability performed according to specification."
Integrated System Performance (Bed, Firmware, iBed™ Mobile)	"Bench performance testing was conducted to ensure the bed software, firmware, and iBed™ Mobile performed together according to specification."
Usability/Design Validation (Remote Parameter Management)	"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."
Safety and Compliance (Electrical, Wireless, Software, Risk)	The device was "designed, tested, and confirmed to comply with recognized safety and performance standards applicable to General Healthcare facility Medical Devices." (References include IEC 60601 series for electrical safety, IEEE 802.11 for WiFi, IEC 62304 for software lifecycle, ISO 14971 for risk management, and various FDA guidance documents for software, cybersecurity, EMC, and human factors.) Specific tests mentioned include Signal Integrity, Integration (Graybox, Software-to-Software, Software-to-Hardware), Lifecycle, Power Cycle, Low Power, Max Power Consumption, Security, WiFi Interoperability, Coexistence, Durability, Environmental, Static Analysis, Power Short, Blackbox, Performance, System, Usability, Torture Track, Drop Test, Box and Label Chemical and Cleaning, Roaming Test, Targeted Vulnerability Testing, Internal Testing, Impact Test, and Penetration. The conclusion is that differences "do not raise new questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified in terms of number of beds, users, or distinct test cases beyond the general descriptions of "testing" and "design validation." This is typical for a 510(k) focusing on engineering and software validation for a non-AI accessory.
Data Provenance: The testing appears to be primarily conducted internally by Stryker Medical in a simulated environment ("simulated-use environment"). No mention of external or real-world clinical data from specific countries. The testing is prospective in nature, as it's part of the development and validation process for the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

"Design validation testing was conducted in a simulated-use environment by health care professionals."
The number of healthcare professionals is not specified.
Their qualifications are generally stated as "health care professionals," but no specific details (e.g., specific roles, years of experience, board certifications) are provided. Their role in "establishing ground truth" is less about making a clinical judgment (like diagnosing a condition) and more about confirming the device's functionality and usability aligns with their professional needs for bed management.

4. Adjudication Method for the Test Set

No formal adjudication method is mentioned, as the "ground truth" is based on the device's adherence to its functional specifications and successful operation by healthcare professionals in a simulated environment, rather than a subjective interpretation task (e.g., image reading). The focus is on technical verification and validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed. The document explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence to the predicate device."
This device is an accessory for remote bed management, not a diagnostic tool where human readers interpret data. Therefore, a comparative effectiveness study measuring human reader improvement with AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study in the context of an AI algorithm's independent diagnostic accuracy was performed.
The device's "standalone" performance would be its ability to transmit and receive data, and apply parameter changes correctly, as verified through "software verification testing" and "bench performance testing." This is covered by the engineering and software validation.

7. Type of Ground Truth Used

The "ground truth" for this device's validation is primarily engineering specifications, functional requirements, and user-defined operational needs.
- For software and bench testing, ground truth is whether the system performs "according to specification."
- For usability/design validation, ground truth is whether healthcare professionals can "successfully set, adjust, and monitor bed status parameters... as intended."
It is not expert consensus on a clinical condition, pathology reports, or patient outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is an accessory with defined functional capabilities, not a machine learning or AI algorithm that "learns" from a training set. Its functionality is hard-coded based on design specifications.

9. How Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" for this device. Its "ground truth" relates to its engineered design and verified performance against those design requirements.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: catherine.friday@stryker.com t: (269) 312-0684

Date of Summary: 13 May 2021

II. SUBJECT DEVICE

Device Trade orProprietary Name:	iBed™ Wireless with iBed™ MobileModel 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

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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/PatientStatus	View Only	Displays room location, patient fall risk, andbed protocol notifications, bed serial number
B	Bed Status	View only	Displays HOB >30, bed height, nurse callconnected, brake, siderail position, bed exitsensitivity.
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

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 DeviceiBed™ Wireless with iBed™	Predicate DeviceiBed™ Wireless with iBed™
Device Characteristic	Mobile (K202964)	Awareness (K103536)	Differences
Device Trade orProprietary Name	iBed™ Wireless with iBed™Mobile	iBed™ Wireless with iBed™Awareness	Addition of iBed™ MobileiBed™ Awareness wasrenamed iBed™ Watch.
Product Model Number	5212	Same	None
Common or Usual Name	AC-Powered AdjustableHospital Bed (Accessory)	Same	None
Regulation Number	21 CFR 880.5100510(k) Exempt	Same	None
Classification Name	AC-Powered AdjustableHospital Bed	Same	None
Product Code	FNL	Same	None
Class	Class II	Same	None
Review Panel	General Hospital	Same	None
Intended Use	The iBed™ Wireless withiBed™ Mobile deviceaccessory's intended use is toprovide healthcare professionalsthe ability to set, adjust, andmonitor specific bed parametersfrom a remote location within ahealthcare delivery	The intended use for the iBed™Wireless with iBed™Awareness is to assist clinicalstaff to monitor bed parameterson specific Stryker Medicalbeds. The monitoredparameters include bed brakes,side rail position, bed exit, etc.	Subject device can set, adjust,and monitor specific bed statusparameters. Predicate devicecan only monitor bed status.The Intended Use statement forthe iBed™ Wireless withiBed™ Mobile device isnotidentical to the predicate

Table 2: Comparison of Technological Characteristics with the Predicate Device
	Subject DeviceiBed™ Wireless with iBed™	Predicate DeviceiBed™ Wireless with iBed™
Device Characteristic	Mobile (K202964)	Awareness (K103536)	Differences
	organization's facility using bi-directional data communication.The desired bed parameters willbe initially set by healthcareprofessionals at bedside. TheiBed™ Wireless with iBed™Mobile device accessory isintended to be used only withspecifically enabled Strykerbeds that have been verified andvalidated with the iBed®Wireless software and is notintended to provide bed statusinformation for non-Strykerbeds. Patient healthinformation is notcommunicated or stored.	The desired bed parameters willbe set by clinicians at thebedside. The iBed™ Wirelesssoftware is intended to be usedonly with specifically enabledStryker Medical beds that havebeen verified and validated withthe iBed™ Wireless softwareand is not intended to providebed status information for non-Stryker Medical beds. TheiBed™ Wireless software is notintended to communicate anypatient status information nor topermanently store any type ofdata.	device; however, thedifferences do not alter theintended use of the device nordo they affect the safety andeffectiveness of the devicerelative to the predicate. Boththe subject and predicatedevices have the same intendeduse for the ability to monitor thepatient's bed parameters, eitherfrom a stationary nurse stationas in the predicate device or viathe mobile application in thesubject device.
Indications for Use	The intended patient populationis dependent on the StrykerMedical bed location within thehealthcare deliveryorganization. The iBed™Wireless with iBed™ Mobileaccessory does not change theexisting populations for whichthese beds serve.	Same	None
Device Characteristic	Subject DeviceiBed™ Wireless with iBed™Mobile (K202964)	Predicate DeviceiBed™ Wireless with iBed™Awareness (K103536)	Differences
Primary Function	Bi-directional datacommunication for activating orviewing bed status parameters.	One-way data communicationfor viewing bed statusparameters.	Subject device utilizes bi-directional data transmissionthat allow remote activation andviewing.
Intended PatientPopulation	Patients confined to ahealthcare delivery organizationbed (not for use in a home ornon-institutional long-term carefacility setting).	Same	None
Intended Users	Healthcare Professionals	Same	None
Operational Environment	Must be used in a healthcaredelivery organization.	Same	None
Bed Status Parameters -Location/Status	• Remote viewing of:o Room locationo Patient fallrisko Bed protocolnotificationso Bed serial number	• Remote viewing of:o Room location	Subject device added remoteviewing of patient fall risk, bedprotocol notifications, and bedserial number.
Device Characteristic	Subject DeviceiBed™ Wireless with iBed™Mobile (K202964)	Predicate DeviceiBed™ Wireless with iBed™Awareness (K103536)	Differences
Bed Status Parameters -Bed Status	• Monitoring of:o HOB angle >30o Bed heighto Nurse call connectedo Brake (locked/unlocked)o Siderail positiono Bed exit zone andsensitivity	Same	None
Bed Status Parameters -Bed Motion	• Bedside and remote lockingof bed motion• Bedside and remotemonitoring of bed exitsensitivity	• Bedside locking of bedmotion• Bedside and remotemonitoring of bed exitsensitivity	Remote activation using Subjectdevice.
Bed Status Parameters -Bed Exit	• Bedside and remoteactivation• Bedside and remote statusmonitoring	• Bedside activation• Bedside and remote statusmonitoring	Remote activation using Subjectdevice.
Bed Status Parameters -Bed and Patient PositionMonitoring	• iBed™ Watch	• iBed™ Awareness	None. iBed™ Awareness wasrenamed as iBed™ Watch.
Bed Status Parameters -Patient Fall Risk	• Displays assessment andscore	• Not available	Subject device function only.
Bed Status Parameters -Rounding	• Displays assessment andscore	• Not available.	Subject device function only.
Device Characteristic	Subject DeviceiBed™ Wireless with iBed™Mobile (K202964)	Predicate DeviceiBed™ Wireless with iBed™Awareness (K103536)	Differences
Bed Status Parameters –Support Surface Settings(if available)	• Remote display ofassessment and score	• Not available	Subject device function only.
Bed Status Parameters –Bed Scales	• Remote display of scaleinformation	Same	None
Installation	1. Configure bed for wirelessconnection to the centralhealthcare DeliveryOrganization's InformationSystem network server.2. Install iBed™ Mobileapplication fromrelevantmobile application stores(i.e. Apple).3. Configure iBed™ Mobilefor use.	1. Install iBed™ Locator intothe room / bay.2. Associate iBed™ Locator tothe healthcare deliveryorganization's room / bay.Upgrade bed software (ifneeded).3. Configure bed for wirelessconnection to the privatehealthcare deliveryInformation Systemnetwork server.	Subject device requires theiBed™ Mobile application to beinstalled on handheld electronicdevice and configured to thehealthcare deliveryorganization's protocols.
User Operation	1. The healthcare professionalinitially sets bed parametersettings at bedside.2. Data is automatically sent toserver and downloaded tomonitoring station andSubject device.	1. The healthcare professionalinitially sets bed parametersettings at bedside.2. Data is automatically sent toserver and downloaded tomonitoring station.	Subject device provides theability to set, adjust, andmonitor bed status parametersfrom remote location within thehealthcare deliveryorganization.
Device Characteristic	Subject DeviceiBed™ Wireless with iBed™Mobile (K202964)	Predicate DeviceiBed™ Wireless with iBed™Awareness (K103536)	Differences
	3. The healthcare professionalcompletes her/his review ofthe bed parameters atmonitoring station or usingthe iBed™ Mobileapplication.Based on healthcaredelivery organization(HDO) protocols, thehealthcare professionalmay set, adjust, and/orcontinue monitoring bedparameters.	3. The healthcare professionalcompletes her/his review ofthe bed parameters atmonitoring station.4. Healthcare provider able tomonitor bed parametersfrom a different locationwithin the healthcaredelivery organization.5. If adjustments are needed,the healthcare professionalmust be bedside to makethem.	The Predicate device must havebed adjustments made atbedside and can be monitored abedside and nurse station.
Primary Device Function	Bi-directional data transmissionof specific bed parametersbetween HDO's centralInformation System softwaresystem.	One-way directional datatransmission of specific bedparameters between HDO'scentral Information Systemsoftware system.	Subject device utilizes bi-directional data communicationversus the Predicate device'sone-way data communication.
User Interface	The bed's footboard panel mustbe used to initially set bedstatus parameters.	Same	None
	The iBed™ Mobile applicationadds the following GUI screens:● Login● List View	Adjustments must be made atbedside.	iBed™ Mobile
Device Characteristic	Subject DeviceiBed™ Wireless with iBed™Mobile (K202964)	Predicate DeviceiBed™ Wireless with iBed™Awareness (K103536)	Differences
	• Room View• iBed Watch Status• Falls Tab• Rounding Tab• Skin Tab• Scale Tab
Main System Components	• iBed™ Wireless WiFiModule (Bed)• Bi-directional iBed™Wireless Software• iBed™ Mobile• iBed™ Watch	• iBed™ Wireless WiFiModule (Bed)• Uni-directional iBed™Wireless Software• iBed™ Awareness	iBed™ Mobile
Wireless Communications– Data Transmission	Bi-directional datatransmission:Bed to server to iBed™ Mobileto healthcare professional andthen back to iBed™ Mobilethen back to server then back tobed.	Uni-directional datatransmission:Bed to server.	Two-way data transmissionversus one-way datatransmission.
Wireless Communications– WiFi Radio Module	WiFi module - IEEE 802.11a/b/g/n/ac (bi-directional)	WiFi module - IEEE 802.11 b/g(uni-directional)	Subject device moduleupgraded to next generationradio.
Device Characteristic	Subject DeviceiBed™ Wireless with iBed™Mobile (K202964)	Predicate DeviceiBed™ Wireless with iBed™Awareness (K103536)	Differences
(Houses Data TransmissionSoftware)
Database	Healthcare deliveryorganization's centralInformation System softwareserver.	Same	None

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VII. NON-CLINICAL PERFORMANCE DATA

Design verification and validation testing was performed on the iBed™ Wireless with iBed™ Mobile device as a result of risk analysis and product requirements. Testing requirements 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 Stryker Medical bed software, firmware, and iBed™ Mobile performed together according to specification.

Biocompatibility testing and non-clinical animal testing were not required to demonstrate substantial equivalence to the predicate device.

The following guidance and standards were used for performance testing:

Guidance for the Content of Premarket Submissions for Software Contained in Medical . Devices, May 11, 2005
Radio-Frequency Wireless Technology in Medical Devices - Draft Guidance, August 14, 2013
. Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, September 27, 2019
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, . Draft Guidance, October 18, 2018
. Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, July 11, 2016
Applying Human Factors and Usability Engineering to Medical Devices, Guidance for . Industry and Food and Drug Administration Staff, February 3, 2016
ISO 14971, 2nd Edition, 2007-03-01 Medical devices Application of risk management . to medical devices (FDA consensus standard 5-40)
ANSI/AAMI/IEC 60601-1:2005/ (R)2012 and A1:2012 Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text, FDA consensus standard 19-4)
. IEC 60601-1-2, Edition 4.0, 2014-02 - Medical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FDA consensus standard 19-8)

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IEC 60601-2-52. Edition 1.0. 2009-12 Medical electrical equipment Part 2-52: Particular . requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)] (FDA consensus standard 6-321)
. IEEE 802.11:2013 - IEEE Standard for Information technology -- Telecommunications and information exchange between systems -- Local and metropolitan area networks-Specific requirements -- Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications
. AIM 7351731, Rev. 2.00, 2017-02-23 - Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers -An AIM Standard (FDA consensus standard 19-30)
IEC 62304-1 Edition 1.0 2016-10 Medical device software Software lifecycle ● processes, published 4/7/2016 (FDA consensus standard 13-79)
AAMI TIR69:2017 Technical Information Report Risk management of radio-frequency . wireless coexistence for medical devices and systems (FDA consensus standard 19-22)
. IEC TIR 80001-2-2, Edition 1.0 2012-07 - Application of risk management for ITnetworks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls (FDA consensus standard 13-42)
IEC TIR 80001-2-8, Edition 1.0 2016-05 Application of risk management for IT-. networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2 (FDA consensus standard 13-102)
. NIST SP 800-53, Revision 4 - Security and Privacy Controls for Federal Information Systems and Organizations
IEEE C63.27 – 2017 - American National Standard for Evaluation of Wireless Coexistence (FDA consensus standard 19-29)
RSS-247 Issue 2:2017 Digital Transmission Systems (DTSs), Frequency Hopping . Systems (FHSs) and License - Exempt Local Area Network (LE-LAN) Devices
. 47 CFR 15 Subpart C and E - Radio Frequency Devices (United States) - Licensing with Federal FCC

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The following tests were conducted on iBed™ Wireless with iBed™ Mobile:

Signal Integrity Testing .
Integration Testing: Graybox Testing .
Integration Testing: Software to . Software
Integration Testing: Software to . Hardware
Lifecycle Testing .
. Power Cycle Testing
Low Power Testing ●
Max Power Consumption ●
Security Testing .
. WiFi Interoperability Test
Coexistence
Durability
Environmental ●
Static Analysis
Power Short ●
. Blackbox Testing
Performance Testing .
System Testing ●
Usability Testing ●
Torture Track Testing ●
Drop Test ●
Box and Label Chemical and ● Cleaning
Roaming Test .
. Targeted Vulnerability Testing
Internal Testing ●
Impact Test ●
Penetration .
Input Test .

VIII. CLINCAL PERFORMANCE TESTING

Clinical Studies were not required to demonstrate substantial equivalence to the predicate device.

IX. CONCLUSIONS

The iBed™ Wireless with iBed™ Mobile device is substantially equivalent to the legally marketed predicate device as the difference in the technological characteristics for accessing and ability to view or change some specific bed parameters does not raise new questions of safety and effectiveness as compared to the predicate. The iBed™ Wireless with iBed™ Mobile device has the same intended use and indications for use as the predicate device for monitoring of in-bed activity and information transmission to health care providers about patient status for patients using hospital beds in the HDO facility. The subject device does have different technological characteristics from the predicate. However these differences do not raise new questions of safety and effectiveness. Non-clinical performance data demonstrates that the subject device is substantially equivalent to the predicate.

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The iBed™ Wireless with iBed™ Mobile device has been designed, tested, and confirmed to comply with recognized safety and performance standards applicable to General Healthcare facility Medical Devices. Based on the iBed™ Wireless with iBed™ Mobile's technological characteristics, completed non-clinical bench testing, and when compared with the predicate device, Stryker Medical concludes the iBed™ Wireless with iBed™ Mobile is substantially equivalent to the predicate device the iBed™ Wireless with iBed™ Awareness (K103536).

Regulation Number and Section

§ 880.5100 AC-powered adjustable hospital bed.

(a)
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.(b)
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.