(293 days)
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.
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.
The Hill-Rom TotalCare® Modular Therapy (Bed) System is a medical bed designed to provide patient support and therapy.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Source | Reported Device Performance |
|---|---|---|
| Functional, Performance, Safety, and Efficacy | Hill-Rom's verification and validation based on international standards | Meets functional, performance, safety, and efficacy specifications and requirements in compliance with listed international standards. |
| Compliance with International Standards | IEC 60601-1 (General Safety) | Compliant |
| IEC 60601-1-2 (EMC Requirements) | Compliant | |
| IEC 60601-1-4 (Programmable Electrical Medical Systems) | Compliant | |
| IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds) | Compliant | |
| Substantial Equivalence to Predicate Devices | FDA's 510(k) review process | Determined to be substantially equivalent to legally marketed predicate devices. |
| Intended Use | Device Description and Indications for Use | Functions as a patient support system in healthcare environments; treats/prevents pulmonary/immobility complications, pressure ulcers; provides Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy; supports patients up to 500 lbs. |
2. Sample Size for Test Set and Data Provenance
The provided summary does not mention any specific sample sizes for a test set related to clinical performance or algorithm evaluation. Instead, it explicitly states:
- "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."
This indicates that the device's acceptance was primarily based on non-clinical performance and substantial equivalence to predicate devices, without a dedicated clinical test set for this specific submission.
3. Number of Experts and Qualifications for Ground Truth
Given that "Clinical testing was not required," there is no mention of experts used to establish ground truth for a test set in the context of this 510(k) summary. The evaluation relied on compliance with engineering standards and comparison to existing products.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring human assessment, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as clinical testing was not required. The device is a medical bed, not an AI-assisted diagnostic tool for which such studies are typically performed.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done as the device is a medical bed and not an algorithm-based system requiring such evaluation. The evaluation focused on the physical device's compliance with safety and performance standards.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptance was:
- Compliance with international engineering and safety standards: This forms the basis for the non-clinical performance summary (e.g., IEC 60601 series).
- Substantial equivalence to predicate devices: This involves comparing the new device's technological characteristics and intended use to existing, legally marketed similar devices, rather than a clinical ground truth like pathology or outcome data.
8. Sample Size for the Training Set
Since there are no indications of a machine learning or AI algorithm being developed or deployed within this device, there is no mention of a training set sample size.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the question of how its ground truth was established is not applicable.
In Summary:
The Hill-Rom TotalCare® Modular Therapy (Bed) System's acceptance was based on non-clinical performance validation against established international safety and performance standards, and demonstrating substantial equivalence to predicate medical beds. Clinical testing was not deemed necessary for this 510(k) submission, and therefore, typical metrics associated with AI device evaluation (like test set size, expert ground truth, MRMC studies, or training sets) are not present in this documentation.
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Hill-Rom 510(k) submission, K122473
JUN
3 2013
ﻪ ﺳﻮﯾﺘﻪ
510K Summary
| Date Summary wasPrepared: | August 10, 2012 |
|---|---|
| 510(k) Submitted: | Ann Waterhouse, RACDirector, Regulatory Affairs1069 State Route 46 EastBatesville, 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 adjustablehospital bed |
| Device Product Codes andClassification: | IOQ, Class IIBed, floatation therapy, powered (21 CFR 890.5071)FNL, Class IIBed, AC powered adjustable hospital bed (21 CFR 880.5100)FNK, Class IIBed, 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 acontrol unit (GUI) and frame which can house severaltherapeutic surfaces. The system can articulate to providedifferent positions for treatment, sleeping, up-in-bed, andother physician recommended positions. The GraphicalCaregiver Interface/ Graphical User Interface can be set foralarms such as patient egress and head-of-bed angle. |
| Statement of Intended Use: | The TotalCare® Modular Therapy (Bed) System isintended as a patient support system. It is to be used inhealth care environments such as, but not limited to, acutecare, including critical care, step down/progressive care,medical/surgical, high acuity sub-acute care, postanesthesia care unit (PACU), and sections of theemergency department (ED). The TotalCare® Bed Systemis capable of being used with a broad patient population asdetermined appropriate by the caregiver or institution.The TotalCare® Bed System, dependent upon model, iscapable of supporting patient populations up to 500 Ibs. |
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Hill-Rom 510(k) submission, K122473
| Indications for Use: | The TotalCare® Bed System is intended to be used to treator prevent pulmonary or other complications associatedwith immobility; to treat or prevent pressure ulcers; or forany other use where medical benefits may be derived fromeither Continuous Lateral Rotation Therapy orPercussion/Vibration Therapy. The TotalCare® BedSystem is intended to provide a patient support to be usedin health care environments. The TotalCare® Bed Systemmay be used in a variety of settings including, but notlimited to, acute care, including critical care, stepdown/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sectionsof the emergency department (ED). The TotalCare® BedSystem is capable of being used with a broad patientpopulation as determined appropriate by the caregiver orinstitution.The TotalCare® Bed System, dependent upon model, iscapable of supporting patient populations up to 500 lbs. |
|---|---|
| Non-Clinical PerformanceSummary: | Hill-Rom has verified and validated that the TotalCare®Modular Therapy Bed System meets functional,performance, safety and efficacy specifications andrequirements in compliance with the following internationalstandards:IEC 60601-1, Medical Equipment - part 1: GeneralRequirements for Safety, 1990+AI ; 1993+A21995+Al3;11996IEC 60601-1-2; 2001Medical Electrical Equipment Part 1-2General Requirements for Basic Safety and EssentialPerformance-Collateral Standard: ElectromagneticCompatibility Requirements and TestsIEC 60601-1-4; 1996-A 1; 1999 Medical electricalEquipment, Part 1: General requirements for safety-4:Collateral standard: Programmable electrical medicalsystemsIEC 60601-2-38 Particular requirements for the safety ofElectrically Operated hospital beds. |
| Supporting Data: | Clinical testing was not required for determination ofsubstantial equivalence. A literature review was compiled ofarticles related to safe patient handling and benefits oftherapy surfaces and beds of this type for patientsexperiencing prolonged immobility. Those articles can befound 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, andperforming as well as or better than the predicate devices,and therefore is substantially equivalent. |
.
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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.
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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-SDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=Mary S. Runner- | |
|---|---|
| 0.9.2342.19200300.100.1.1=1300087950Date: 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
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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. Chapman2013.06.03 15:01:07-04'00' | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| 510(k) Number: | K122473 |
§ 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.