The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill- Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill- Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Device Description

The Hill-Rom Wireless Connectivity Module is a wireless module installed on specific Hill-Rom bed models. The Hill-Rom Wireless Connectivity Module is integrated into existing bed platforms via a USB connection to the bed's electrical system and provides connectivity to a remote server application.

The Hill-Rom Wireless Connectivity Module is used to assist staff to monitor hospital bed status and to assist the healthcare provider in providing patient care. The optional feature is mounted onto Hill-Rom hospital beds to wirelessly transmit bed information such as: bed exit status, bed side rail status, bed brake status, head of bed angle, and patient weight from bed scale. The Hill-Rom Wireless Connectivity Module is a tool that facilitates the wireless transmission of the bed status data using a wireless hardware and software device which communicates with a remote server in the hospital. The bed status data may be displayed at user-defined locations, such as nursing stations. It may also be shared with EMR (Electronic Medical Record) Systems through integration with 3rd party systems.

AI/ML Overview

This document describes regulatory approval for a medical device called the "Hill-Rom Wireless Connectivity Module," which is a wireless module installed on specific Hill-Rom bed models to transmit bed parameters to a remote server. The information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for device performance in a diagnostic or clinical decision-making context.

Therefore, the requested information cannot be fully provided as the device is not an AI/ML algorithm or a diagnostic tool that would typically undergo such a rigorous performance study. The submission focuses on regulatory compliance, safety, and functionality.

Here's an attempt to answer the questions based on the provided document, highlighting where the requested information is not applicable or not explicitly stated:

1. A table of acceptance criteria and the reported device performance

This document does not provide acceptance criteria and reported performance in the typical sense for a diagnostic device or AI algorithm (e.g., sensitivity, specificity, AUC). Instead, the "performance" is assessed against compliance with international standards for electromagnetic compatibility and usability engineering.

Acceptance Criteria Category (Implied)	Reported Device Performance
Functional & Performance	Meets specifications
Safety	Meets specifications
Efficacy	Meets specifications
Electromagnetic Immunity	Compliant with EN 55024:2010
Radio Disturbance	Compliant with EN 55022:2010
Usability Engineering	Compliant with IEC 62366:2007/(R)2013

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is a hardware module for transmitting existing bed data, not a diagnostic or AI algorithm requiring a test set of patient data. The testing mentioned refers to hardware and software verification and validation, and compliance with standards. No information regarding patient-specific data provenance or sample size for a test set is provided as it's not relevant to this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As explained above, there is no "test set" in the context of diagnostic performance requiring ground truth established by medical experts for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set requiring ground truth adjudication by experts for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a wireless connectivity module for monitoring bed parameters, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a hardware module that transmits data. It does not perform an "algorithm only" task in the sense of an AI model making diagnostic predictions. Its function is to communicate existing bed status data wirelessly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense for a diagnostic device. The "ground truth" for this device would be the actual state of the bed parameters (e.g., bed exit status, side rail status, brake status, head of bed angle, patient weight) as measured inherently by the bed's sensors. The device's performance would be validated by ensuring it accurately transmits these existing bed status data points. The document states "The Wireless Connectivity Module communicates existing bed status data. Clinical testing was therefore not required for determination of substantial equivalence as there is no new data involved in the wireless communication..." This implies the "ground truth" is the direct measurement from the bed itself.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm requiring a training set with established ground truth.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2015

Hill-Rom Ms. Ann Waterhouse Director, Regulatory Affairs 1069 State Route 46 East Batesville, Indiana 47006

Re: K143414

Trade/Device Name: Hill-Rom Wireless Connectivity Module Regulation Number: 21 CFR 880.5100 Regulation Name: AC powered adjustable hospital bed Regulatory Class: II Product Code: FNL Dated: January 29, 2015 Received: January 30, 2015

Dear Ms. Waterhouse:

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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang-S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K143414

Device Name Hill-Rom Wireless Connectivity Module

Indications for Use (Describe)

The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill-Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

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

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

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510(k) Summary

Traditional 510(k): Hill-Rom Wireless Connectivity Module

510(k) Submitter:	Hill-Rom1069 State Route 46 EastBatesville, IN 47006Registration Number: 1824206
Contact Person:	Ann Waterhouse, RAC1069 State Route 46 EastBatesville, IN 47006812-931-3426 (telephone)812-934-1675 (facsimile)
Date Prepared:	25 November 2014
Trade Name:	bed, ac-powered adjustable
Common Name:	Hill-Rom Wireless Connectivity Module
Review Panel:	General Hospital
Classification Name:	bed, ac-powered adjustable ( 21 CFR880.5100, Product Code FNL)
Predicate Name:	iBed™ Wireless with iBed™ Awareness, K103536

Device Description

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Intended Use

Patient Population

The patient population is determined by the medical bed to which the Hill-Rom Wireless Connectivity Module is affixed, however, the use of the wireless module does not change the existing populations which these beds serve, they remain: Critical care, inpatient acute care, step down/progressive care, Medical /surgical, high acuity sub-acute care, post anesthesia care unit (PACU), sections of the emergency department (ED), extended care, long-term care, and skilled nursing facility care.

Comparison of Technological Characteristics

The Hill-Rom Wireless Connectivity Module uses the same fundamental scientific technology as that of the iBed™ Wireless with iBed™ Awareness. Both have the ability to communicate bed status through wireless means. Both accessories are meant to operate with existing hospital bed products. Neither device specific for the purposes of wireless capability: (1) affect the intended use or (2) alter(s) the fundamental scientific technology of the devices to which they are affixed.

Substantial Equivalence

The Hill-Rom Wireless Connectivity Module is equivalent to the previously cleared and commercially distributed iBed™ Wireless with iBed™ Awareness (K103536) in that the Hill-Rom Wireless Connectivity Module is intended to assist clinical staff to monitor bed parameters on specific Hill-Rom beds, and the Stryker iBed™ Wireless with iBed™ Awareness (K103536) is intended to monitor bed parameters of the Stryker product. Both accessories use the same wireless technology (IEEE 802.11), and because they

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are for use with hospital bed products, they must adhere to similar design considerations regarding the product to which they are eventually paired. The energy expectations are those of wireless technology, as are the operating principles.

Non-clinical performance data

Hill-Rom has verified and validated that the Hill-Rom Wireless Connectivity Module meets its functional, performance, safety and efficacy specifications and requirements. Software testing and hardware testing of the final device has been conducted. The device has been tested according to National and International Standards for compliance to these recognized Consensus Standards below:

N/A	EN	EN 55024:2010	Immunity characteristics - Limitsand methods of measurement	Jan 2011	Electromagnetic immunity ofinformation technologyequipment.
N/A	EN	55022:2010	Radio disturbancecharacteristics - Limits andmethods of measurement	Jul 2011	Information technologyequipment, radio disturbancecharacteristics.
5-67	IEC	62366:2007/(R)2013	Medical Devices - Application ofusability engineering to medicaldevices.	Jul 2014	(General I (QS/RM))

The performance testing that has been conducted on the Hill-Rom Wireless Connectivity Module demonstrates that it is as safe and as effective, and performs as well as the predicate device.

Clinical Testing

The Wireless Connectivity Module communicates existing bed status data. Clinical testing was therefore not required for determination of substantial equivalence as there is no new data involved in the wireless communication, subject of this submission.

Conclusion

The data herein supports this device, the Hill-Rom Wireless Connectivity Module, as safe and efficacious as that of the Stryker iBed™ Wireless with iBed™ Awareness, K103536, predicate device and is therefore, substantially equivalent.

Regulation Number and Section

§ 890.5170 Powered flotation therapy bed.

(a)
Identification. A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.(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 § 890.9.