(49 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a stretcher and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as descriptions of training and test sets.
No
The device is described as a wheeled stretcher for patient transport and care, not for treating any specific condition or disease.
No
Explanation: The primary function of this device is patient transport and care, even when fitted with an optional radiolucent surface for image acquisition, it does not inherently perform diagnostic functions or analysis. It facilitates imaging, but is not a diagnostic device itself.
No
The device description clearly describes a physical, wheeled stretcher with hardware components (platform, frame, wheels, side rails, etc.), not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as transporting patients and allowing for patient care before, during, and after transport. This is a physical function related to patient handling and positioning, not the examination of specimens derived from the human body.
- Device Description: The device is described as a wheeled stretcher, a physical apparatus for patient transport.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
- Radiolucent Surface: While the optional radiolucent surface allows for radiographic imaging, the stretcher itself is not performing the diagnostic function. The imaging equipment is the diagnostic device. The stretcher is simply facilitating the imaging process by providing a suitable surface.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. This stretcher does not fit that description.
N/A
Intended Use / Indications for Use
The subject stretcher and predicate are intended to be used with the general population to transport patients and to allow for patient care before, during, and after transport. The stretchers may be used in or for various patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home care. When fitted with the optional radiolucent surface, the stretcher may be used for acquisition of radiographic images.
Product codes
Not Found
Device Description
A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps.
There is some variation in the construction and design of the stretchers but the variations do not significantly affect the safety or efficacy of the stretchers. As with the predicate stretcher, the stretcher which is the subject of this submission will be a movable, caster mounted design with variable height and trendelenburg features. In addition, as with predicate stretcher, the variable height top surface of the stretcher will utilize a twin tower design with two hydraulic cylinders mounted in a vertical orientation near the ends of the base. The Stretcher is designed to meet U.L. and I.E.C. stability requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images
Anatomical Site
Not Found
Indicated Patient Age Range
general population
Intended User / Care Setting
patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home 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
Significant safety and performance characteristics are tested to assure compliance with specifications. Upon completion the test results become part of the device master record as required under the GMP, 21 CFR 820. A complete review of hazards associated with the product was performed. This review included research of complaint, MDR and trade association databases. In addition, identification of other potential structural and performance hazards was completed by engineering. Testing has been developed to assure that these hazards have been eliminated or the severity or probability of occurrence minimized.
The stretcher platform has an optional radiolucent surface. Testing and procedures for the surface have been implemented to assure compliance with performance standards established under 21 CFR 1020 "Performance Standard for Ionizing Radiation Emitting Products."
The device will also comply with the following voluntary standards.
IEC 601-1 Medical electrical equipment; Part 1: General requirements for safety 2nd edition, 1988.
IEC 601-2-38 Medical electrical equipment; Part 2: Particular requirements for the safety of electrical, energized and non-energized hospital beds.
UL 2601-1 First edition of the standard for medical electrical equipment, Part 1: General requirements for safety.
CAN/CSA-C22.2 No. 601.1-M90, Medical electrical equipment; Part 1: General requirements for safety.
IEC 601-1-2 Electromagnetic Compatibility Requirements
Key Metrics
Not Found
Predicate Device(s)
Stryker "Synergy Series" Stretchers
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6910 Wheeled stretcher.
(a)
Identification. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.(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 § 880.9.
0
JUN - 3 1996
April 12, 1996
510(k) PREMARKET NOTIFICATION SUMMARY
Submitter's name and address:
Hill-Rom, Incorporated 1069 St. Route 46 East Batesville, IN 47006
Contact person, telephone number and fax number:
James G. Carpenter Hill-Rom, Incorporated Ph: (812) 934-1671 Fx: (812) 934-1675
Device Trade or proprietary name:
To be determined
Device common or usual name:
Ambulatory care procedural stretcher
Device classification name:
Wheeled Stretcher
Identification of the marketed device(s) to which equivalence is claimed:
Stryker "Synergy Series" Stretchers
Description:
ﻤﺴﺴﺴﺴﺴ
A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps.
1
There is some variation in the construction and design of the stretchers but the variations do not significantly affect the safety or efficacy of the stretchers. As with the predicate stretcher, the stretcher which is the subject of this submission will be a movable, caster mounted design with variable height and trendelenburg features. In addition, as with predicate stretcher, the variable height top surface of the stretcher will utilize a twin tower design with two hydraulic cylinders mounted in a vertical orientation near the ends of the base. The Stretcher is designed to meet U.L. and I.E.C. stability requirements.
The subject stretcher and predicate are intended to be used with the general population to transport patients and to allow for patient care before, during, and after transport. The stretchers may be used in or for various patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home care. When fitted with the optional radiolucent surface, the stretcher may be used for acquisition of radiographic images.
The labels and in-service manual provide information which describes the device, its intended uses, and the directions for operation enabling proper and safe use the product.
Performance standards applicable to wheeled stretchers have not been established under Section 514 of the FD&C Act.
Significant safety and performance characteristics are tested to assure compliance with specifications. Upon completion the test results become part of the device master record as required under the GMP, 21 CFR 820. A complete review of hazards associated with the product was performed. This review included research of complaint, MDR and trade association databases. In addition, identification of other potential structural and performance hazards was completed by engineering. Testing has been developed to assure that these hazards have been eliminated or the severity or probability of occurrence minimized.
The stretcher platform has an optional radiolucent surface. Testing and procedures for the surface have been implemented to assure compliance with performance standards established under 21 CFR 1020 "Performance Standard for lonizing Radiation Emitting Products."
The device will also comply with the following voluntary standards.
IEC 601-1 Medical electrical equipment; Part 1: General requirements for safety 2nd edition, 1988.
2
| IEC 601-2-38 | Medical electrical equipment; Part 2: Particular
requirements for the safety of electrical, energized
and non-energized hospital beds. |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| UL 2601-1 | First edition of the standard for medical electrical
equipment, Part 1: General requirements for
safety. |
| CAN/CSA-C22.2 | No. 601.1-M90, Medical electrical equipment; Part
1: General requirements for safety. |
| IEC 601-1-2 | Electromagnetic Compatibility Requirements |
The subject stretcher and predicate stretcher in this submission are substantially equivalent.
: