(293 days)
Not Found
No
The summary describes a therapeutic bed system with various articulation and alarm features, controlled via a GUI. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML technology in medical devices. The reference to IEC 60601-1+AI refers to an amendment to the standard, not the incorporation of AI in the device itself.
Yes
The device is explicitly stated to "treat or prevent pulmonary or other complications associated with immobility" and "treat or prevent pressure ulcers," which are therapeutic applications.
No
Explanation: The device, the TotalCare® Bed System, is described as providing patient support and therapies to treat or prevent complications, such as pressure ulcers or those associated with immobility. Its function is therapeutic and supportive, not diagnostic (i.e., it does not identify or investigate a disease or condition).
No
The device description explicitly states it is a "control unit (GUI) and frame which can house several therapeutic surfaces," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a bed system used for patient support, therapy (rotation, percussion/vibration), and preventing complications associated with immobility and pressure ulcers. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a bed frame, control unit, and therapeutic surfaces. This aligns with a medical bed, not a device used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring biomarkers
The device is a medical device, specifically a therapeutic bed system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.
Product codes
IOQ, FNL, FNK
Device Description
The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.
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
Not Found
Intended User / Care Setting
health care environments such as, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED).
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
Clinical testing was not required for determination of substantial equivalence. A literature review was compiled of articles related to safe patient handling and benefits of therapy surfaces and beds of this type for patients experiencing prolonged immobility. Those articles can be found in the Clinical articles section of the 510(k).
Key Metrics
Not Found
Predicate Device(s)
K103536, K962942, K970636, K972111
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.
0
Hill-Rom 510(k) submission, K122473
JUN
3 2013
ﻪ ﺳﻮﯾﺘﻪ
510K Summary
| Date Summary was
| Prepared: | August 10, 2012 |
|---|---|
| 510(k) Submitted: | Ann Waterhouse, RAC |
| Director, Regulatory Affairs | |
| 1069 State Route 46 East | |
| Batesville, IN 47006 | |
| (812) 931-2634 | |
| (812) 934-1675 (facsimile) | |
| Device Trade Name: | Hill-Rom TotalCare® Modular Therapy (Bed) System |
| Device Common Name: | Bed, Flotation Therapy, powered Bed, |
| AC powered adjustable hospital bed, Hydraulic adjustable | |
| hospital bed | |
| Device Product Codes and | |
| Classification: | IOQ, Class II |
| Bed, floatation therapy, powered (21 CFR 890.5071) | |
| FNL, Class II | |
| Bed, AC powered adjustable hospital bed (21 CFR 880.5100) | |
| FNK, Class II | |
| Bed, Hydraulic adjustable hospital bed (21 CFR 880.5110) | |
| Predicate Devices: | Stryker iBed Wireless with iBed Awareness (K103536) |
| Hill-Rom TotalCare (K962942) | |
| Hill-Rom TotalCare Modular Therapy System (K970636) | |
| Hill-Rom Rumors DynamicAir (K972111) | |
| Device Description: | The TotalCare® Modular Therapy (Bed) System is a |
| control unit (GUI) and frame which can house several | |
| therapeutic surfaces. The system can articulate to provide | |
| different positions for treatment, sleeping, up-in-bed, and | |
| other physician recommended positions. The Graphical | |
| Caregiver Interface/ Graphical User Interface can be set for | |
| alarms such as patient egress and head-of-bed angle. | |
| Statement of Intended Use: | The TotalCare® Modular Therapy (Bed) System is |
| intended as a patient support system. It is to be used in | |
| health care environments such as, but not limited to, acute | |
| care, including critical care, step down/progressive care, | |
| medical/surgical, high acuity sub-acute care, post | |
| anesthesia care unit (PACU), and sections of the | |
| emergency department (ED). The TotalCare® Bed System | |
| is capable of being used with a broad patient population as | |
| determined appropriate by the caregiver or institution. | |
| The TotalCare® Bed System, dependent upon model, is | |
| capable of supporting patient populations up to 500 Ibs. |
·
1
Hill-Rom 510(k) submission, K122473
| Indications for Use: | The TotalCare® Bed System is intended to be used to treat
or prevent pulmonary or other complications associated
with immobility; to treat or prevent pressure ulcers; or for
any other use where medical benefits may be derived from
either Continuous Lateral Rotation Therapy or
Percussion/Vibration Therapy. The TotalCare® Bed
System is intended to provide a patient support to be used
in health care environments. The TotalCare® Bed System
may be used in a variety of settings including, but not
limited to, acute care, including critical care, step
down/progressive care, medical/surgical, high acuity sub-
acute care, post anesthesia care unit (PACU), and sections
of the emergency department (ED). The TotalCare® Bed
System is capable of being used with a broad patient
population as determined appropriate by the caregiver or
institution.
The TotalCare® Bed System, dependent upon model, is
capable of supporting patient populations up to 500 lbs. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Performance
Summary: | Hill-Rom has verified and validated that the TotalCare®
Modular Therapy Bed System meets functional,
performance, safety and efficacy specifications and
requirements in compliance with the following international
standards:
IEC 60601-1, Medical Equipment - part 1: General
Requirements for Safety, 1990+AI ; 1993+A2
1995+Al3;11996
IEC 60601-1-2; 2001Medical Electrical Equipment Part 1-2
General Requirements for Basic Safety and Essential
Performance-Collateral Standard: Electromagnetic
Compatibility Requirements and Tests
IEC 60601-1-4; 1996-A 1; 1999 Medical electrical
Equipment, Part 1: General requirements for safety-4:
Collateral standard: Programmable electrical medical
systems
IEC 60601-2-38 Particular requirements for the safety of
Electrically Operated hospital beds. |
| Supporting Data: | Clinical testing was not required for determination of
substantial equivalence. A literature review was compiled of
articles related to safe patient handling and benefits of
therapy surfaces and beds of this type for patients
experiencing prolonged immobility. Those articles can be
found in the Clinical articles section of the 510(k). |
| Conclusion: | The data herein supports this device, Hill-Rom TotalCare®
Modular Therapy (Bed) System as safe, effective, and
performing as well as or better than the predicate devices,
and therefore is substantially equivalent. |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2013
Ms. Ann Waterhouse Director of Regulatory Affairs Hill-Rom 1069 Sate Route46 East BATESVILLE, IN 47006-9167
Re: K122473
Trade/Device Name: TotalCare®™ Modular Therapy System Regulation Number: 21 CFR 890.5170 Regulation Name: Powered Flotation Therapy Bed Regulatory Class: II Product Code: IOQ Dated: May 10, 2013 Received: May 21, 2013
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. Iisting 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.
3
Page 2 - Ms. Waterhouse
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
| Susan Runner, DDS, MA | |
|---|---|
| -- | ----------------------- |
| | Digitally signed by Mary S. Runner-S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner- |
|--|-----------------------------------------------------------------------------------------------------------------------|
| | 0.9.2342.19200300.100.1.1=1300087950
Date: 2013.06.03 15:18:41 -04'00' |
| Kwame Ulmer M.S. | |
|---|---|
| Acting Division Director | |
| Division of Anesthesiology, General Hospital, | |
| Respiratory, Infection Control and | |
| Dental Devices | |
| Office of Device Evaluation | |
| Center for Devices and | |
| Radiological Health |
Enclosure
4
Indications for Use
510(k) Number (if known): _K122473
Device Name: Hill-Rom TotalCare®™ Modular Therapy System
Indications for Use:
The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.
| Prescription Use
(Part 21 CFR 801 Subpart D) | Over-The-Counter Use X
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | -------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | Richard C. Chapman
2013.06.03 15:01:07
-04'00' |
|-----------------------------------------------------------------------------------|------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital
Infection Control, Dental Devices | |
| 510(k) Number: | K122473 |