(213 days)
The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility.
Examples of usage include:
- a single operator may move empty beds to staging or storage areas within the healthcare facility.
- a single operator may move patient-laden beds from one location to another within the healthcare facility.
The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility.
Only the caregiver, not the patient, can control this powered assistive device.
This device is not permanently attached to or made a part of the stretcher or bed.
The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.
The provided text describes a 510(k) summary for the IRSG Bed Mover, a device intended to assist a single caregiver in moving hospital beds and stretchers. However, it does not contain information about acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a medical device with performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in human performance).
The submission focuses on establishing substantial equivalence to predicate devices based on intended use, basic movement technology, and performance characteristics, but it does not detail specific performance studies with quantitative acceptance criteria.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- Table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory classification, intended use, device description, and comparison to predicate devices, asserting "substantial equivalence" rather than reporting distinct performance metrics against predefined acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable in this context. There isn't a "test set" of data in the sense of a machine learning or diagnostic device that requires data for evaluation. The device is a bed mover, and its evaluation relies on comparison to existing devices and compliance with safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant to a bed mover.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic tool, so there are no "human readers" in this context, nor an AI component to compare against. Its purpose is mechanical assistance, not diagnostic improvement.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a human-operated mechanical aid, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. The device is a hardware product, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
What is present in the document related to "acceptance criteria" and "study":
The "acceptance criteria" for this type of device, as per the 510(k) summary, are primarily centered around substantial equivalence to predicate devices and compliance with voluntary standards for safety.
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Acceptance Criteria (Implicit - based on 510(k) requirements):
- Substantial Equivalence: The IRSG Bed Mover must be substantially equivalent in intended use, technological characteristics, and performance to legally marketed predicate devices.
- Safety Standards: Compliance with relevant voluntary safety standards, specifically IEC 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety).
- No New Issues of Safety or Effectiveness: The minor differences from predicate devices should not raise new concerns.
- Biocompatibility: Not applicable since the device does not contact the patient.
- Labeling and Instructions: Provision of clear labels and manuals for safe operation.
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"Study" (as described):
The document doesn't describe a formal clinical study or a quantitative performance validation study with specific metrics. Instead, the "study" is implicitly the 510(k) submission process itself, which argues for substantial equivalence based on:- Device Comparison: Directly comparing the IRSG Bed Mover to two predicate devices:
- Stryker Powered Wheeled Stretcher with Zoom™ Drive Wheel (K022309)
- Paramed Systems Paraglyde™ DCS TM-1 (FPO, 880.6910, Class II, 510k exempt)
The comparison asserts that the IRSG bed mover is "substantially equivalent... in function, technological characteristics and intended use."
- Safety Standard Compliance: A statement that "The bed mover will comply with the following voluntary standards IEC 60601-1..." This implies that the device was designed to meet these standards, and presumably evidence of this compliance was provided in the full 510(k) submission (though not detailed in the summary).
- Risk Assessment (Implicit): Discussion points address potential safety concerns, stating that "The IRSG i-mover for beds does not contact the patient, so biocompatibility is not a concern," and that labeling addresses safe operation.
- Device Comparison: Directly comparing the IRSG Bed Mover to two predicate devices:
In summary, for the IRSG Bed Mover, the "acceptance criteria" were met by demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards, rather than through a performance study with quantitative metrics for the device itself.
§ 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.