(102 days)
Not Found
No
The description focuses on wireless transmission of bed status data and integration with existing systems, with no mention of AI/ML algorithms for analysis or decision support.
No
The device is described as assisting clinical staff to monitor bed parameters and facilitate the wireless transmission of bed status data, not to provide treatment or therapy to a patient.
No
The device is intended to monitor bed parameters and facilitate the wireless transmission of bed status data to assist clinical staff. It explicitly states that it is "not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment," and "All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional." This indicates it does not diagnose medical conditions.
No
The device description explicitly states it is a "wireless hardware and software device" and mentions "hardware testing" in the performance studies summary.
Based on the provided text, the Hill-Rom Wireless Connectivity Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Device Function: The Hill-Rom Wireless Connectivity Module's intended use and description clearly state that its purpose is to monitor bed parameters (bed exit, side rail, brake, head angle, weight) and transmit this data wirelessly. It does not involve the analysis of biological specimens.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any type of human specimen.
- Focus on Bed Status: The device is focused on the status and functionality of the medical bed itself, not on analyzing patient samples.
Therefore, the Hill-Rom Wireless Connectivity Module falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FNL
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.
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 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.
Intended User / Care Setting
Assists clinical staff to monitor bed parameters.
Care settings include: 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.
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
Not Found
Summary of Performance Studies
Study type: Non-clinical performance data, Software testing and hardware testing.
Sample size: Not Specified
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: 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: EN 55024:2010, EN 55022:2010, IEC 62366:2007/(R)2013. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
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.
1
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) | |
|---|---|
| ------------------------------------------------- | -- |
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-Rom
1069 State Route 46 East
Batesville, IN 47006
Registration Number: 1824206 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann Waterhouse, RAC
1069 State Route 46 East
Batesville, IN 47006
812-931-3426 (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 CFR
880.5100, Product Code FNL) |
| Predicate Name: | iBed™ Wireless with iBed™ Awareness, K103536 |
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.
4
Intended Use
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.
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
5
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 - Limits
and methods of measurement | Jan 2011 | Electromagnetic immunity of
information technology
equipment. |
|------|-----|--------------------|----------------------------------------------------------------------------------|----------|----------------------------------------------------------------------------|
| N/A | EN | 55022:2010 | Radio disturbance
characteristics - Limits and
methods of measurement | Jul 2011 | Information technology
equipment, radio disturbance
characteristics. |
| 5-67 | IEC | 62366:2007/(R)2013 | Medical Devices - Application of
usability engineering to medical
devices. | 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.