Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for remote monitoring and control of hospital beds, focusing on data transmission and convenience. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No
This device is a convenience tool for healthcare professionals to monitor and adjust hospital bed parameters remotely; it does not directly treat or diagnose a medical condition in a patient.

Diagnostic

No

The device is described as 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." It focuses on controlling and monitoring the physical settings of a hospital bed, not on diagnosing medical conditions from patient data.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of both "iBed™ Wireless (WiFi module)" and the "iBed™ Mobile software application," indicating a hardware component (the WiFi module) is part of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The iBed™ Wireless with iBed™ Mobile accessory is described as a tool to assist healthcare professionals in setting, adjusting, and monitoring bed parameters from a remote location. It facilitates data transmission about the bed's status and settings.
No Biological Samples: The description explicitly states that the device transfers bed status and parameter data and does not store this data. There is no mention of collecting or analyzing biological samples from a patient.
Focus on Bed, Not Patient Diagnosis: The intended use and device description focus entirely on the functionality and status of the hospital bed itself, not on diagnosing, treating, or monitoring a patient's medical condition through analysis of their biological samples.

Therefore, the iBed™ Wireless with iBed™ Mobile accessory falls outside the scope of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

Product codes (comma separated list FDA assigned to the subject device)

FNL

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The intended patient population is dependent on the Stryker Medical bed location within the healthcare delivery organization. The iBed™ Wireless with iBed™ Mobile accessory does not change the existing populations for which these beds serve.

Intended User / Care Setting

Healthcare professionals in a healthcare delivery organization.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K103536

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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 or
Proprietary Name: | iBed™ Wireless with iBed™ Mobile
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
Status	View Only	Displays room location, patient fall risk, and
bed protocol notifications, bed serial number
B	Bed Status	View only	Displays HOB >30, bed height, nurse call
connected, brake, siderail position, bed exit
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
iBed™ Wireless with iBed™ | Predicate Device
iBed™ Wireless with iBed™ | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Characteristic | Mobile (K202964) | Awareness (K103536) | Differences |
| Device Trade or
Proprietary Name | iBed™ Wireless with iBed™
Mobile | iBed™ Wireless with iBed™
Awareness | Addition of iBed™ Mobile
iBed™ Awareness was
renamed iBed™ Watch. |
| Product Model Number | 5212 | Same | None |
| Common or Usual Name | AC-Powered Adjustable
Hospital Bed (Accessory) | Same | None |
| Regulation Number | 21 CFR 880.5100
510(k) Exempt | Same | None |
| Classification Name | AC-Powered Adjustable
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
iBed™ Mobile device
accessory's intended use is to
provide healthcare professionals
the ability to set, adjust, and
monitor specific bed parameters
from a remote location within a
healthcare delivery | The intended use for the iBed™
Wireless with iBed™
Awareness is to assist clinical
staff to monitor bed parameters
on specific Stryker Medical
beds. The monitored
parameters include bed brakes,
side rail position, bed exit, etc. | Subject device can set, adjust,
and monitor specific bed status
parameters. Predicate device
can only monitor bed status.
The Intended Use statement for
the iBed™ Wireless with
iBed™ Mobile device isnot
identical to the predicate |

Table 2: Comparison of Technological Characteristics with the Predicate Device
	Subject Device
iBed™ Wireless with iBed™	Predicate Device
iBed™ Wireless with iBed™
Device Characteristic	Mobile (K202964)	Awareness (K103536)	Differences
	organization's facility using bi-
directional data communication.
The desired bed parameters will
be initially set by healthcare
professionals at bedside. The
iBed™ Wireless with iBed™
Mobile device accessory is
intended to be used only with
specifically enabled Stryker
beds that have been verified and
validated with the iBed®
Wireless software and is not
intended to provide bed status
information for non-Stryker
beds. Patient health
information is not
communicated or stored.	The desired bed parameters will
be set by clinicians at the
bedside. The iBed™ Wireless
software is intended to be used
only with specifically enabled
Stryker Medical beds that have
been verified and validated with
the iBed™ Wireless software
and is not intended to provide
bed status information for non-
Stryker Medical beds. The
iBed™ Wireless software is not
intended to communicate any
patient status information nor to
permanently store any type of
data.	device; however, the
differences do not alter the
intended use of the device nor
do they affect the safety and
effectiveness of the device
relative to the predicate. Both
the subject and predicate
devices have the same intended
use for the ability to monitor the
patient's bed parameters, either
from a stationary nurse station
as in the predicate device or via
the mobile application in the
subject device.
Indications for Use	The intended patient population
is dependent on the Stryker
Medical bed location within the
healthcare delivery
organization. The iBed™
Wireless with iBed™ Mobile
accessory does not change the
existing populations for which
these beds serve.	Same	None
Device Characteristic	Subject Device
iBed™ Wireless with iBed™
Mobile (K202964)	Predicate Device
iBed™ Wireless with iBed™
Awareness (K103536)	Differences
Primary Function	Bi-directional data
communication for activating or
viewing bed status parameters.	One-way data communication
for viewing bed status
parameters.	Subject device utilizes bi-
directional data transmission
that allow remote activation and
viewing.
Intended Patient
Population	Patients confined to a
healthcare delivery organization
bed (not for use in a home or
non-institutional long-term care
facility setting).	Same	None
Intended Users	Healthcare Professionals	Same	None
Operational Environment	Must be used in a healthcare
delivery organization.	Same	None
Bed Status Parameters -
Location/Status	• Remote viewing of:
o Room location
o Patient fallrisk
o Bed protocol
notifications
o Bed serial number	• Remote viewing of:
o Room location	Subject device added remote
viewing of patient fall risk, bed
protocol notifications, and bed
serial number.
Device Characteristic	Subject Device
iBed™ Wireless with iBed™
Mobile (K202964)	Predicate Device
iBed™ Wireless with iBed™
Awareness (K103536)	Differences
Bed Status Parameters -
Bed Status	• Monitoring of:
o HOB angle >30
o Bed height
o Nurse call connected
o Brake (locked/unlocked)
o Siderail position
o Bed exit zone and
sensitivity	Same	None
Bed Status Parameters -
Bed Motion	• Bedside and remote locking
of bed motion
• Bedside and remote
monitoring of bed exit
sensitivity	• Bedside locking of bed
motion
• Bedside and remote
monitoring of bed exit
sensitivity	Remote activation using Subject
device.
Bed Status Parameters -
Bed Exit	• Bedside and remote
activation
• Bedside and remote status
monitoring	• Bedside activation
• Bedside and remote status
monitoring	Remote activation using Subject
device.
Bed Status Parameters -
Bed and Patient Position
Monitoring	• iBed™ Watch	• iBed™ Awareness	None. iBed™ Awareness was
renamed as iBed™ Watch.
Bed Status Parameters -
Patient Fall Risk	• Displays assessment and
score	• Not available	Subject device function only.
Bed Status Parameters -
Rounding	• Displays assessment and
score	• Not available.	Subject device function only.
Device Characteristic	Subject Device
iBed™ Wireless with iBed™
Mobile (K202964)	Predicate Device
iBed™ Wireless with iBed™
Awareness (K103536)	Differences
Bed Status Parameters –
Support Surface Settings
(if available)	• Remote display of
assessment and score	• Not available	Subject device function only.
Bed Status Parameters –
Bed Scales	• Remote display of scale
information	Same	None
Installation	1. Configure bed for wireless
connection to the central
healthcare Delivery
Organization's Information
System network server.

Install iBed™ Mobile
application fromrelevant
mobile application stores
(i.e. Apple).
Configure iBed™ Mobile
for use. | 1. Install iBed™ Locator into
the room / bay.
Associate iBed™ Locator to
the healthcare delivery
organization's room / bay.
Upgrade bed software (if
needed).
Configure bed for wireless
connection to the private
healthcare delivery
Information System
network server. | Subject device requires the
iBed™ Mobile application to be
installed on handheld electronic
device and configured to the
healthcare delivery
organization's protocols. | |
| User Operation | 1. The healthcare professional
initially sets bed parameter
settings at bedside.
Data is automatically sent to
server and downloaded to
monitoring station and
Subject device. | 1. The healthcare professional
initially sets bed parameter
settings at bedside.
Data is automatically sent to
server and downloaded to
monitoring station. | Subject device provides the
ability to set, adjust, and
monitor bed status parameters
from remote location within the
healthcare delivery
organization. | |
| Device Characteristic | Subject Device
iBed™ Wireless with iBed™
Mobile (K202964) | Predicate Device
iBed™ Wireless with iBed™
Awareness (K103536) | Differences | |
| | 3. The healthcare professional
completes her/his review of
the bed parameters at
monitoring station or using
the iBed™ Mobile
application.
Based on healthcare
delivery organization
(HDO) protocols, the
healthcare professional
may set, adjust, and/or
continue monitoring bed
parameters. | 3. The healthcare professional
completes her/his review of
the bed parameters at
monitoring station.
Healthcare provider able to
monitor bed parameters
from a different location
within the healthcare
delivery organization.
If adjustments are needed,
the healthcare professional
must be bedside to make
them. | The Predicate device must have
bed adjustments made at
bedside and can be monitored a
bedside and nurse station. | |
| Primary Device Function | Bi-directional data transmission
of specific bed parameters
between HDO's central
Information System software
system. | One-way directional data
transmission of specific bed
parameters between HDO's
central Information System
software system. | Subject device utilizes bi-
directional data communication
versus the Predicate device's
one-way data communication. | |
| User Interface | The bed's footboard panel must
be used to initially set bed
status parameters. | Same | None | |
| | The iBed™ Mobile application
adds the following GUI screens:
● Login
● List View | Adjustments must be made at
bedside. | iBed™ Mobile | |
| Device Characteristic | Subject Device
iBed™ Wireless with iBed™
Mobile (K202964) | Predicate Device
iBed™ Wireless with iBed™
Awareness (K103536) | Differences | |
| | • Room View
• iBed Watch Status
• Falls Tab
• Rounding Tab
• Skin Tab
• Scale Tab | | | |
| Main System Components | • iBed™ Wireless WiFi
Module (Bed)
• Bi-directional iBed™
Wireless Software
• iBed™ Mobile
• iBed™ Watch | • iBed™ Wireless WiFi
Module (Bed)
• Uni-directional iBed™
Wireless Software
• iBed™ Awareness | iBed™ Mobile | |
| Wireless Communications
– Data Transmission | Bi-directional data
transmission:
Bed to server to iBed™ Mobile
to healthcare professional and
then back to iBed™ Mobile
then back to server then back to
bed. | Uni-directional data
transmission:
Bed to server. | Two-way data transmission
versus one-way data
transmission. | |
| Wireless Communications
– WiFi Radio Module | WiFi module - IEEE 802.11
a/b/g/n/ac (bi-directional) | WiFi module - IEEE 802.11 b/g
(uni-directional) | Subject device module
upgraded to next generation
radio. | |
| Device Characteristic | Subject Device
iBed™ Wireless with iBed™
Mobile (K202964) | Predicate Device
iBed™ Wireless with iBed™
Awareness (K103536) | Differences | |
| (Houses Data Transmission
Software) | | | | |
| Database | Healthcare delivery
organization's central
Information System software
server. | 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).