(20 days)
Not Found
No
The description focuses on a battery-powered drive mechanism for easier transportation, with no mention of AI or ML capabilities.
No
The device is described as assisting caregivers in the treatment and transportation of patients, primarily functioning as a movable stretcher with features for patient support and transportation, not as a device that delivers therapeutic intervention.
No
Explanation: The device is a procedural stretcher with a powered drive system designed for patient transportation and positioning, not for diagnosing medical conditions. While it includes a scale for weighing patients, this is a measurement tool and does not constitute a diagnostic function in the broader sense of identifying or characterizing diseases.
No
The device description explicitly states it includes a "battery-powered drive mechanism which is integrated into the stretcher platform" and is a "permanently attached powered drive". This indicates 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 is to "assist caregivers in the treatment and transportation of patients." This describes a device used directly on or with a patient for physical support and movement.
- Device Description: The description details a physical stretcher with features for patient support, positioning, and transportation. It does not mention any components or processes related to examining specimens from the human body.
- 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.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The Hill-Rom Procedural Stretcher with Intellidrive is a medical device used for patient handling and transport, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
Product codes
INK
Device Description
The Hill-Rom Procedural Stretcher product is a movable, castermounted stretcher. The product has side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. The stretcher is available with an optional that consists of the addition of a battery-powered drive mechanism which is integrated into the stretcher platform provides propulsion of the platform along the floor with minimal force applied by the caregiver. The powered drive mechanism is only controllable by the caregiver and not the patient. The Intellidrive® option aids in the transportation of patients by providing healthcare personnel with the ability to more easily move and maneuver the stretcher.
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
caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities.
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, sample size, AUC, MRMC, standalone performance, key results)
Hazards for the product were identified in a systematic manner. A list of known or foreseeable hazards associated with the product both in normal and fault conditions was compiled and evaluated. A comprehensive review of field complaints, MDR's and recalls from similar Hill-Rom products and the predicate device was conducted and included in the hazard identification process. This review was conducted by a cross-functional team composed of members from Engineering, Quality, Regulatory Affairs, and Clinical.
A verification and validation plan has been developed that defines the testing parameters that ensure that the product meets its design requirements and that the hazards that were identified were eliminated by design features or that the occurrence rate is a low as reasonably possible. The testing was conducted on both a system level, with the system being the entire stretcher, and a module level, with the module being the Intellidrive mechanism. Safety and performance characteristics of the device were identified via customer needs and functional requirements of the device. The characteristics were converted into requirements that were verified and validated successfully. The product also successfully meets the following voluntary standards:
Medical Electrical Equipment: Part 1: General Requirements for Safety - UL 60601-1 (1st Ed., 25-Apr-03, Rev 26-Apr-06);
Medical Electrical Equipment: Part 1: General Requirements for Safety - General Instruction No. 1 - CAN/CSA C22.2 601.1-M90 (1st Ed., Nov-90, R2005) + Supplement No. 1-94 (C22.2 No. 601.1S1-94, Feb-94, R1999) + Amendment 2:1998 (Feb-98, R2006) + Update No. 2 (Nov-03, R2005);
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988: Amendment 1, 1991-11, Amendment 2, 1995. (General);
IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)
IEC 60601-2-38 1996/Amendment 1:1999, Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds. (General Plastic Surgery/General Hospital)
IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (General)
Based on the information from stretcher test results and a review of the predicate device's functions and features, any differences described between the Hill-Rom Procedural Stretcher with Intellidrive® and that of the predicate device do not raise new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics of the system are the same.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Powered Wheeled Stretcher, #K022309
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3690 Powered wheeled stretcher.
(a)
Identification. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).(b)
Classification. Class II (performance standards). The powered wheeled stretcher is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9, and the following conditions for exemption:(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.
0
Image /page/0/Picture/1 description: The image shows the logo for Hill-Rom. The logo is in a rounded rectangle shape. The text "Hill-Rom" is in a bold, sans-serif font and is white. The background of the logo is black.
Device Owner:
Hill-Rom Company 1069 State Route 46 East Batesville, Indiana 47006
Traditional 510(k) Submission: Procedural Stretcher with Intellidrive®
510(k) Summary Hill-Rom Procedural Stretcher with Intellidrive®
SEP 1 9 2011
Hill-Rom, Inc. 1069 State Route 46 East Batesville, IN 47006-9167 Phone: 812-934-777
Contact: Chad Hodson (812)-934-1278 Fax: (812)-931-3481 Registration Number: 1824206
Date Summary Prepared: 6/30/11
Device Names:
Trade Name: Hill-Rom Procedural Stretcher with Intellidrive® Common Name: Powered stretcher Classification Name: Stretcher, Wheeled, Powered, (21 CFR 890.3690, Product Code INK)
Regulatory Class: Class II
Predicate Devices: Stryker Powered Wheeled Stretcher, #K022309
Device Description: The Hill-Rom Procedural Stretcher product is a movable, castermounted stretcher. The product has side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. The stretcher is available with an optional that consists of the addition of a battery-powered drive mechanism which is integrated into the stretcher platform provides propulsion of the platform along the floor with minimal force applied by the caregiver. The powered drive mechanism is only controllable by the caregiver and not the patient. The Intellidrive® option aids in the transportation of patients by providing healthcare personnel with the ability to more easily move and maneuver the stretcher.
The Hill-Rom Procedural Stretcher with Intellidrive® meets the requirements of IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). The device carries the ETL marking to UL60601-1 and CAN/CSA C22.2 NO, 601.1-M90.
Intended Use: The Hill-Rom Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive® Transport System is a permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
1
Image /page/1/Picture/0 description: The image shows the logo for Hill-Rom. The logo is in a rounded rectangle shape. The text "Hill-Rom" is in a bold, sans-serif font and is white with a black outline. The background of the logo is a textured, dark color.
Hill.Rom Comnany 1069 State Route 46 East Batesville, Indiana 47006
Traditional 510(k) Submission: Procedural Stretcher with Intellidrive®
Similarities and Differences:
The Hill-Rom Procedural Stretcher with Intellidrive® is substantially equivalent in function and intended use to the Stryker® Powered Wheeled Stretcher. Each is intended to provide assistance to caregivers in the treatment and transportation of patients in healthcare facilities.
The predicate device is a Class II device, classified at 21 C.F.R. and 890.3690, Stretcher, Wheeled, Powered, Product Code INK. This is the same classification as the device being submitted.
As with the predicate device, this product is a movable, caster-mounted stretcher. Both products have side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. In both products, the addition of a powered transport mechanism to a normal transport stretcher enables the caregiver to move the stretcher with very little applied force.
Hazards for the product were identified in a systematic manner. A list of known or foreseeable hazards associated with the product both in normal and fault conditions was compiled and evaluated. A comprehensive review of field complaints, MDR's and recalls from similar Hill-Rom products and the predicate device was conducted and included in the hazard identification process. This review was conducted by a cross-functional team composed of members from Engineering, Quality, Regulatory Affairs, and Clinical.
A verification and validation plan has been developed that defines the testing parameters that ensure that the product meets its design requirements and that the hazards that were identified were eliminated by design features or that the occurrence rate is a low as reasonably possible. The testing was conducted on both a system level, with the system being the entire stretcher, and a module level, with the module being the Intellidrive mechanism. Safety and performance characteristics of the device were identified via customer needs and functional requirements of the device. The characteristics were converted into requirements that were verified and validated successfully. The product also successfully meets the following voluntary standards:
Medical Electrical Equipment: Part 1: General Requirements for Safety - UL 60601-1 (1st Ed., 25-Apr-03, Rev 26-Apr-06);
Medical Electrical Equipment: Part 1: General Requirements for Safety - General Instruction No. 1 - CAN/CSA C22.2 601.1-M90 (1st Ed., Nov-90, R2005) + Supplement No. 1-94 (C22.2 No. 601.1S1-94, Feb-94, R1999) + Amendment 2:1998 (Feb-98, R2006) + Update No. 2 (Nov-03, R2005);
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988: Amendment 1, 1991-11, Amendment 2, 1995. (General);
IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)
2
Image /page/2/Picture/0 description: The image shows the logo for Hill-Rom. The logo is in a rounded rectangle shape. The text "Hill-Rom" is in bold, white letters with a black outline. The background of the logo is black.
Hill-Rom Company 1069 State Route 46 East Batesville, Indiana 47006
Traditional 510(k) Submission: Procedural Stretcher with Intellidrive®
IEC 60601-2-38 1996/Amendment 1:1999, Medical electrical equipment - Part 2-38: Particular requirements for the safety of electrically operated hospital beds. (General Plastic Surgery/General Hospital)
IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. (General)
Based on the information from stretcher test results and a review of the predicate device's functions and features, any differences described between the Hill-Rom Procedural Stretcher with Intellidrive® and that of the predicate device do not raise new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics of the system are the same.
A summary table is included on the following page that compares the new device and the predicate device.
Prepared by: Chad Hodson Senior Regulatory / Quality Engineer Hill-Rom Company
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Image /page/3/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text around the perimeter reads "U.S. Department of Health & Human Services". The symbol in the center consists of three stylized lines that appear to be flowing or waving.
Food and Drug Administration 10905 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hill-Rom Company % Intertek Testing Services NA, Inc. Ms. Paula Wilkerson 2307 E. Aurora Road / Unit B7 Twinsburg, OH 44087
SEP 1 9 2011
Re: K112502
Trade/Device Name: Hill-Rom® Procedural Stretcher with Intellidrive® Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: II Product Code: INK Dated: September 15, 2011 Received: September 16, 2011
Dear Ms. Wilkerson:
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.
ff 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
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Page 2 - Ms. Paula Wilkerson
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Hill-Rom. The logo is in a rounded rectangle shape. The text "Hill-Rom." is in a sans-serif font and is outlined in black.
Hill-Rom Company 1069 State Route 46 East Batesville. Indiana 47006
Traditional 510(k) Submis Procedural Stretcher with Intellidrive "
Indications for Use
510(k) Number (if known): ___ TBD
Device Name: Hill-Rom® Procedural Stretcher with Intellidrive®
Indications for Use:
The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112502